Atlas FDA

1996

4,407 FDA 510(k) clearances · Clearance year

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RecordFirmDate
FLEX-LASE 600 SERIES ION LASER SYSTEM (K963389)American Laser Medical1996-11-26
IRRIGATION/SUCTION HANDLE AND SHEATH (K963757)Richard Wolf Medical Instruments Corp.1996-11-26
OXI TEMP (K963496)Bci Intl., Inc.1996-11-26
DEXIS MODEL 601 DENTAL ELECTRONIC IMAGING SYSTEM (K962631)Fair Image, Inc.1996-11-26
9TH WAVE MODELS 400 & 450 ALTERNATING PRESSURE MATTRESS (K963626)9th Wave, Inc.1996-11-26
STRYKER SUCTION REGULATOR (K963648)Stryker Endoscopy1996-11-26
STARKEY TM AIR CONDUCTION TINNITUS MASKER (K963838)Starkey Laboratories, Inc.1996-11-26
APREMA I - ALTERNATING PRESSURE AIR FLOTATION MATTRESS SYSTEM (K963510)Mellen Air Mfg., Inc.1996-11-26
SPERM PREPARATION MEDIA (K962816)Genx Intl., Inc.1996-11-26
ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT (K962045)Mallinckrodt Medical1996-11-26
STERILE AND NON-STERILE O.R. TOWELS, STERILE AND NON-STERILE X-RAY DETECTABLE O.R. TOWELS, SINGLE USE (K962205)Medline Industries, Inc.1996-11-26
MENTOR TONO-PEN 3 (K964312)Mentor Ophthalmics, Inc.1996-11-26
AHS DELTA 22 T (K963881)Authorized Hearing Systems, Inc.1996-11-26
AHS OMEGA AGC (K963874)Authorized Hearing Systems, Inc.1996-11-26
LA PLATA 34 (PM-25) (K964465)Gateway Alloys, Inc.1996-11-26
DISPOSABLE SCALP VEIN INFUSION SET (K953252)Myco Medical Supplies, Inc.1996-11-26
KARL STORZ POINT COAGULATOR, SEMM CROCODILE FORCEPS, MYOMA ENUCLEATOR (K955756)KARL STORZ Endoscopy-America, Inc.1996-11-26
GAUZE COMPRESS (K960615)Certified Safety Mfg., Inc.1996-11-25
SUNGLASSES(NON-PRESCRIPTION) (K964413)Ever Prime Enterprises , Ltd.1996-11-25
HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROID MICROSOMAL (TPO) (K962451)Hycor Biomedical, Inc.1996-11-25
HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROGLOBULIN (TG) (K962341)Hycor Biomedical, Inc.1996-11-25
SPENSER SUNGLASSES AND SPORT SUNGLASSES (K964058)Spencer Products Co.1996-11-25
SUNGLASSES (K964082)Neo Vu, Inc.1996-11-25
ACRI ILIAC CREST ASPIRATION BIOPSY NEEDLES (K962568)Gallini Intl., Inc.1996-11-25
CONTRAST STRIP HCG (K964156)Genzyme Diagnostics1996-11-25
INSTANT HOT PACKS (K963768)Kick Ice, Inc.1996-11-25
VIT COMMANDER SYSTEM (K961738)Scieran Technologies, Inc.1996-11-25
ONTRAK TESTTCUP COLLECTION/URINALYSIS PANEL (K964422)Roche Diagnostic Systems, Inc.1996-11-25
C-REACTIVE PROTEIN (CRP):A LATEX SLIDE TEST (K962019)Teco Diagnostics1996-11-25
ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER (K963397)Boston Scientific Corp1996-11-25
VISCOUS FLUID SYSTEM (K963434)Escalon Trek Medical1996-11-25
ANSPACH SUTURE ANCHOR (MODIFIED) (K963686)The Anspach Effort, Inc.1996-11-25
HEALTH O METER ELECTRIC HEATING PAD W/MASSAGE MODEL EHP4 (K962252)Sunbeam Health Division1996-11-25
MITEK ELECTROSURGICAL SYSTEM FOR ARTHROSCOPIC USE (K963783)ETHICON, Inc.1996-11-25
HY-TEC/MANUAL AUTOIMMUNE KIT FOR HISTONE (K962450)Hycor Biomedical, Inc.1996-11-25
HY-TEC/MANUAL AUTOIMMUNE KIT FOR MITOCHONDRIA (K962452)Hycor Biomedical, Inc.1996-11-25
SUCTION CATHETER TRAY PRODUCT NO. 900277 (K964011)Customed, Inc.1996-11-25
CD 19 R-PE, CD19 TRI-COLOR MONOCLONAL ANTIBODY (K963954)Caltag Laboratories, Inc.1996-11-25
VENTREX OXYGEN SENSOR (K963415)Ventrex, LLC1996-11-25
BLOCK STOP WIRES (K964087)Ferguson Medical1996-11-25
MODEL 1310 NEUROLINK NEUROMONITORING SYSTEM (K962157)Physiometrix, Inc.1996-11-25
RHEUMATOID FACTOR (RF) REAGENTI A LATEX SLIDE TEST (K962015)Teco Diagnostics1996-11-25
TRACE RITE SOLID GEL ECG ELECTRODES (K964213)Bio-Detek, Inc.1996-11-25
CONTRAST HCG URINE/SERUM TEST AND RAPID HCG URINE/SERUM TEST (K964155)Genzyme Diagnostics1996-11-25
WRPAROUND LIMB HOLDER (24446,24446-350,24447-010,24449-010) (K963559)Tecnol Medical Products, Inc.1996-11-22
PARAMAX AMMONIA AND AMMONIA BLANK REAGENT (K964565)Dade Intl., Inc.1996-11-22
HOLOGIC QDR SERIES X-RAY BOE DENSITOMETERS (K963363)Hologic, Inc.1996-11-22
PHASED ARRAY SHOULDER COIL (K963356)Philips Medical Systems (Cleveland), Inc.1996-11-22
UNISEAL GLOVES (LOW PROTEIN,POWDER FREE) (K963211)American Healthcare Products, Inc.1996-11-22
PROTECTIVE RESTRAINT (WAIST HOLDER) (K963421)Kenad SG Medical, Inc.1996-11-22
WHOLE BLOOD GLUCOSE CONTROL LEVEL 1,2,AND 3/WHOLE BLOOD GLUCOSE LINEARITY CONTROL-LEVEL1,2,3,4,5,AND 6 (K964278)Clinical Controls, Inc.1996-11-22
SILICONE RUBBER CUFF/DISPOSABLE FLEECE LINER'S WEB TORSO RESRAINT,NYON LIMB HOLDER,VINYL LIMB HOLDER,NYLON BED RESTRAINS (K963485)Humane Restraint, Inc.1996-11-22
CDR-CAM (K963778)Schick Technologies, Inc.1996-11-22
PROTECTIVE RESTRAINT (PROTECTIVE MITT) (K963422)Kenad SG Medical, Inc.1996-11-22
RESTRAINT ACCESSORIES (K963436)J. T. Posey Co.1996-11-22
POSEY STRAIGHT JACKETS (K963410)J. T. Posey Co.1996-11-22
PERSONAL LIMB HOLDER (24444-200,300,24444-KIT) (K963564)Tecnol Medical Products, Inc.1996-11-22
RETRIEVAL SNARE (K963750)Boston Scientific Corp1996-11-22
TEX-CARE STERILE STOCKINETTE (K955749)Flynt Amtex, Inc.1996-11-22
QUICK RELEASE LIMB HOLDER (24442,24442-050,24442-350) (K963552)Tecnol Medical Products, Inc.1996-11-22
PROTECTIVE RESTRAINT (VEST RESTRAINT) (K963430)Kenad SG Medical, Inc.1996-11-22
DRESSING CHANGE TRAYS (K963260)Busse Hospital Disposables, Inc.1996-11-22
JACKETS AND VESTS (K963442)J. T. Posey Co.1996-11-22
MULTIPLE BELTS (K963414)J. T. Posey Co.1996-11-22
ENDO VIP (K963323)Richard Wolf Medical Instruments Corp.1996-11-21
ULTRA CARE VEST STYLE BODY HOLDER, SMALL (24455-010,020,030,040,24456-010,020,030,040) (K963561)Tecnol Medical Products, Inc.1996-11-21
COMFOR FOAM LIMB HOLDERS- SINGLE STRAP (K963462)Bird & Cronin, Inc.1996-11-21
24448-010 SECURE-ALL FINGER CONTROL MITT (K963554)Tecnol Medical Products, Inc.1996-11-21
GEMINI PC-ITX (K960512)Imed Corp.1996-11-21
DISPOSABLE SS-F32 ENDOSHEATH FOR USE WITH THE S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE (K963344)Vision-Sciences, Inc.1996-11-21
SYSTEM 2 ZIPPERED BODY HOLDER, SMALL/MEDIUM 24453-010,24453-020,24453-030 (K963557)Tecnol Medical Products, Inc.1996-11-21
SPEED-CUT (K961407)Gallini Intl., Inc.1996-11-21
BACTEC FUNGAL MEDIUM (K954923)Becton Dickinson Diagnostic Instrument Systems1996-11-21
VASCUTEK CARDIOVASCULAR FABRIC: VASCUTEK GELSEAL PATCH,VASCUTEK GELSOFT PATCH,VASCUTEK THIN WALL CAROTID PATCH (K963611)Vascutek, Ltd.1996-11-21
TEBCO (THORACIC ELECTRICAL BIOIMPEDANCE CARDIAC OUTPUT) (K962128)Hemo Sapiens, Inc.1996-11-21
SECURE-ALL 1-PIECE BODY HOLDER, SMALL/MEDIUM (24451-010,020,24452-010,020,030) (K963556)Tecnol Medical Products, Inc.1996-11-21
RADIONICS SLUIJTER-MEHTA CANNULA (K963577)Radionics, Inc.1996-11-21
VITALMAX 4000/MINIPACK 3100/3000 (K951226)Pace Tech, Inc.1996-11-21
N PROTEIN STRANDARD SL (K964062)Behring Diagnostics, Inc.1996-11-21
EUROMEDICAL REINFORCED ENDOTRACHEAL TUBE (K962389)Unomedical Sdn Bhd1996-11-21
ULTRACARE VEST STYLE BODY HOLDER WITH SAFETY SLEEVES, SMALL(24454-010,020,030,040,015,025,035,045,115,125,135,145) (K963563)Tecnol Medical Products, Inc.1996-11-21
24457-010 SECURE ALL PELVIC HOLDER/24458-010 SECURE ALL BODY BELT (K963773)Tecnol Medical Products, Inc.1996-11-21
RDI LDL PRECIPITATION REAGENT (K964063)Reference Diagnostics, Inc.1996-11-20
PALLADIA 75 (PM-11) (K964466)Gateway Alloys, Inc.1996-11-20
CEDIA PHENYTOIN II ASSAY (K963840)Boehringer Mannheim Corp.1996-11-20
MEDTRONIC MUSTANG STEERABLE GUIDE WIRE (M-45FR, M45FX) (K961917)Medtronics Interventional Vascular1996-11-20
COOL-ZONE (K963809)Kappler USA1996-11-20
LATEX EXAMINATION GLOVES, POWDERED (K963742)Arista Medi Prima1996-11-20
TIDAL WAVE CARBON DIOXIDE MONITOR, MODEL 610 (K963327)Novametrix Medical Systems, Inc.1996-11-20
LIFESTYLE GP (TELEFOCON B) RIGID GAS PERMEABLE MULTIFOCAL CONTACT LENS FOR DAILY WEAR (K963010)Permeable Technologies, Inc.1996-11-20
METRO FOCAL ASPHERIC (POLYMACON) (K961606)Metro Optics of Austin, Inc.1996-11-20
FLAVORED LATEX PATIENT EXAMINATION (K960315)P.T. Irama Dinamika Latex1996-11-20
RDI LIPIDIRECT MAGNETIC LDL REAGENT (K964064)Reference Diagnostics, Inc.1996-11-20
SPECIALTY PROGRESSIVE(METHAFILCON A)MULTIFOCAL SOFT(HYDROPHILIC)CONTACT LENS FOR DAILY WEAR(CLEAR AND TINTED) (K963488)Specialty Ultravision, Inc.1996-11-20
ZOMED PASSIVE TEMPERATURE PROBE (K964286)Zomed Intl.1996-11-19
ANSPAHC SPEED REDUCER (K960630)The Anspach Effort, Inc.1996-11-19
KOH COLPOTOMIZER SYSTEM (K954311)CooperSurgical, Inc.1996-11-19
KARL STORZ MODEL 264305-20 ELECTRONIC ENDOFLATOR (K962863)KARL STORZ Endoscopy-America, Inc.1996-11-19
VARIOUS SUNGLASSES (NON-PRESCRIPTION) (K963890)Italian Eyewear, Inc.1996-11-19
MIDAS REX III MOTOR (K962483)Midas Rex Pneumatic Tools, Inc.1996-11-19
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Track 1996 automatically

Every clearance here is in the API, with alerts when new ones post.