Atlas FDA

1994

5,762 FDA 510(k) clearances · Clearance year

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RecordFirmDate
MICRON-SCOPE II (K926412)Chiron Vision Corp.1994-07-19
BIOFIX ABSORBABLE SELF-REINFORCED POLY-L-LACTIDE (K925098)Bioscience, Inc.1994-07-19
BII-PORE (K933688)Bio-Interfaces, Inc.1994-07-19
SPLASH MASK (K941932)Incon Diversified Industries, Inc.1994-07-19
BII-PORE(TM) CANAL WALL PROSTHESIS (K934049)Bio-Interfaces, Inc.1994-07-19
ACT CONTROL SET (K940840)Sigma Diagnostics, Inc.1994-07-19
HYSTEROSCOPE (K934286)Bei Medical Systems Co., Inc.1994-07-19
SURE-CLOSURE II 75MM SKIN STRETCHING SYSTEM (K942526)Life Medical Sciences, Inc.1994-07-19
LORREX POST OPERATIVE SPONGES (K942691)Lorons International Corp.1994-07-19
O-R-EZ TIP CLEANER (K942957)O-R-Ez, Inc.1994-07-19
KOLSTER METHODS (K935820)Kolster Methods1994-07-19
MED-EVAC-4 MEDICAL EVACUATION STRETCHER (K942356)Montery Bay Corp.1994-07-19
TRANSIT INFUSION CATHETER (NEUROVASCULAR USE) (K936282)Cordis Neurovascular, Inc.1994-07-18
SIMPLA S4, S5, S7 (K941447)Simpla Plastics , Ltd.1994-07-18
COSTELLO-EVERETT LASER CYSTOSCOPE SHEATH (K942573)Richard Hamer Assoc., Inc.1994-07-18
MED-TEC, INC. BREAST BOARD, MT-250 (K935411)Medtec, Inc.1994-07-18
MEDICAM 900 REMOTE (K941773)M.P. Video, Inc.1994-07-18
MEDIX BIOTECH BESTEST STREP A CAT. NO. BSF1010 (K932482)Medix Biotech, Inc.1994-07-18
UNI-FRAME HEAD IMMOBILIZATION SYSTEM (K933227)Medtec, Inc.1994-07-18
QUICKVUE IN-LINE ONE-STEP STREP A TEST (K934484)Quidel Corp.1994-07-18
NEUROLOGICAL LEADS (PACKAGING MODIFICATION) (K940416)Medtronic Vascular1994-07-18
XOMED-TREACE SCOPESHEATH (K933672)Xomed-Treace, Inc.1994-07-18
THYROGLOBULIN AUTOANTIBODY ENZYME IMMUNOASSAY (K936010)Biomerica, Inc.1994-07-18
VAC-LOK IMMOBILIZATION SYSTEM (K935300)Medtec, Inc.1994-07-18
ADVANTAGE WINDOWS DIAGNOSTIC X-RAY WORKSTATION (K942120)GE Medical Systems1994-07-18
HI-PRO/NOAH UNIVERSAL HEARING INSTRUMENT (K942749)Madsen Electronics (Canada) , Ltd.1994-07-18
ABBOTT PRISM ANALYZER (K940289)Abbott Mfg., Inc.1994-07-18
TEC 2101 (MODEL MT-HPLGD) (K941169)Medtec, Inc.1994-07-18
ACS HI-TORQUE EXTRA S'PORT GUIDE WIRE (K942066)Advanced Cardiovascular Systems, Inc.1994-07-18
OPHTHALMIC CRYO UNIT (K940373)Dutch Ophthalmic USA, Inc.1994-07-18
MED-TEC, INC. BREAST BOARD, MT-200 (K935412)Medtec, Inc.1994-07-18
NATURAL-KNEE CONGRUENT TIBIAL INSERT WITH SCREW (K931651)Intermedics Orthopedics1994-07-18
EUTRA GEL FOR WOUND DRESSING (K932291)Swiss American Products, Inc.1994-07-18
MED-TEC BREAST SUPPORT SYSTEM (K942282)Medtec, Inc.1994-07-18
RICHARD ROD LENS LARYNGOSCOPE (K941264)Smith & Nephew Richards, Inc.1994-07-18
ACE CLINICAL CHEMISTRY SYSTEM (K941489)Schiapparelli Biosystems, Inc.1994-07-18
CHLAMYDIA TRACHOMATIS ANTIGEN TEST (K941714)Neogenex1994-07-18
KIRSCHNER C-2 OSTEOCAP TOTAL HIP SYSTEM (K935951)Kirschner Medical Corp.1994-07-18
IMPLANTECH DORSAL NASAL IMPLANT (K942876)Implantech Associates, Inc.1994-07-18
NERVE FIBER ANALYZER (K941705)Carl Zeiss Meditec, Inc.1994-07-18
VELO ACE (K940540)Emix U.S.A., Inc.1994-07-18
360 DEG. ROTATING 1/2 BEAM BLOCK (K941719)Medtec, Inc.1994-07-18
U-TOP ENTERPRISE CO SPECTACLE FRAMES & SUNGLASSES (K942119)U-Top Enterprise Co., Ltd.1994-07-15
RETURN PATH DIATHERMY HANDLE (K941495)Mira, Inc.1994-07-15
NON-PRESCRIPTION SUNGLASSES (K936072)King'S Sunglass Corp.1994-07-15
PACING LEAD MODEL 1188T (K925038)Siemens-Pacesetter, Inc.1994-07-15
SURGI-WIPE (K942642)Surgin Surgical Instrumentation, Inc.1994-07-15
DUPEL IONTOPHORESIS DEVICE (K915444)Empi1994-07-15
MICROPHOR (K913601)Life-Tech Intl., Inc.1994-07-15
ARTHROSTIM MANIPULATOR (K930431)Freeman Procedure Seminars1994-07-15
NIDEK MODEL VT-4000, MODIFICATION (K936302)Nidek, Inc.1994-07-15
SEIKO EYEGLASS FRAME (K942513)Seiko Optical Products of America, Inc.1994-07-15
NON-PRESCRIPTION SUNGLASSES (K942783)Sunpoint Import Co., Inc.1994-07-15
IPI DUAL LUMEN PORT (K934167)Pudenz-Schulte Medical Research Corp.1994-07-14
IMMOBILE STERILE AND IMMOBILE A/C STERILE (K941940)Tnt Moborg Intl. , Ltd.1994-07-14
COMFORT KEYBOARD SYSTEM (K930044)Health Care Keyboard Co., Inc.1994-07-14
IPI LOW PROFILE IMPORT (K934796)Pudenz-Schulte Medical Research Corp.1994-07-14
AGALLOY, DISALLOY, EPSILON AND LAMBDA (K942430)Fen Dental Mfg., Inc.1994-07-14
CHARGED SUPOR(R) FILTER EXTENSION SET (K940980)B. Braun of America, Inc.1994-07-14
RH-801, MODEL TRANSQ (K925806)Iomed, Inc.1994-07-14
BIOMEK SL WITH BIOMEK SL INCUBATOR (K941498)Beckman Analytical and Biotechnology Development1994-07-14
SOF-SET QR INFUSION SETS, MODELS MMT-115 AND MMT-116 (K942181)Medtronic Minimed1994-07-14
IMMOBILE NON-STERILE AND IMMOBILE A/C NON-STERILE (K941850)Tnt Moborg Intl. , Ltd.1994-07-14
STANBIO Y-GT (LIQUICOLOR) TEST SET (K941315)Stanbio Laboratory1994-07-14
BIOPSY TRAY (K941645)Cush Medical Products1994-07-14
AIA-PACK TT3 ASSAY (K936229)Tosoh Medics, Inc.1994-07-14
RH-806, MODEL TRANSQ (K925800)Iomed, Inc.1994-07-14
SR1 DHEA-S ENZYME IMMUNOASSAY (K942051)Serono Diagnostics, Inc.1994-07-13
DIGOXIN FPIA REAGENT SET AND CALIBRATOR SET (K940569)Sigma Diagnostics, Inc.1994-07-13
QUICK CORE II (K941256)Proact, Ltd.1994-07-13
EMC FLEXIBLE BIOPSY FORCEPS (K941816)Enterprise Medical Corp.1994-07-13
AIRFRAME SURGICAL DRAPE SUPPORT (K942699)Alpha Surgical, Inc.1994-07-13
ENDOSCOPE (K935818)Cuda Products Co.1994-07-13
DISPOSABLE BACTERIOLOGICAL FILTER (K942779)Vitalograph, Inc.1994-07-13
CHEMTRAK LIQUID UNASSAYED THERAPEUTIC DRUG CONTROLS (K936166)Medical Analysis Systems, Inc.1994-07-13
ADJUSTABLE BITE CORRECTOR (K942492)Orthoplus, Inc.1994-07-13
DRAGER DVE 8000/1/2 SERIES SYST W/DVE 4002 AND 8032E (K942043)Alm Surgical Equipment, Inc.1994-07-13
PROVIDER ANNE INFUSER (K922702)Abbott Laboratories1994-07-13
KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM POROUS COATED (K934589)Kirschner Medical Corp.1994-07-13
CONSENSUS(TM) HIP SYSTEM-HA COATED TIANIUM FEM STEM (K935453)U.S. Medical Products, Inc.1994-07-13
THE SIGNATURE SERIES, IMC IV (K933194)Progressive Electrical Therapeutics1994-07-13
CAP 400 AT (K935272)Pryon Corp.1994-07-13
F-220 PRESS-FIT FEMORAL HIP STEM SYSTEM (K935990)Implex Corp.1994-07-13
THEOPHYLLINE FPIA REAGENT SET AND CALIBRATORS (K942192)Sigma Diagnostics, Inc.1994-07-13
KIRSCHNER INTEGRITY ACETABULAR CUP MODIFICATION (K935206)Kirschner Medical Corp.1994-07-13
METASYS AMALGAM SEPARATOR MST1 (K934500)Metasys Dental Products, Inc.1994-07-13
PURITAN-BENNETT COMPANION 320 I/E BI-LEVEL RESPIRATORY SYSTEM (K935784)Puritan-Bennett1994-07-13
CONMED SELECT-ONE LAPAROSCOPIC ELECTROSURGICAL BLADE (K942892)Conmedcorp1994-07-13
DEFEND SELF-SEALING STERILIZATION POUCH (K932056)Carl Parker Associates, Inc.1994-07-13
ISOCOMFORTER (K936143)Isocomforter, Inc.1994-07-12
WENZHOU IMPORT AND EXPORT CORP (K940627)Sunny Sunglasses1994-07-12
SCHOOL MASCOT EYEWEAR (K942652)School Mascot Eyewear, Inc.1994-07-12
NON-PRESCRIPTION SUNGLASSES (K941441)Sun-Set Enterprise Co. , Ltd.1994-07-12
SUNGLASSES TOKYO BAY (K942500)Tokyo Bay, Inc.1994-07-12
CORDIS OPTA 5(TM) PTA BALLOON CATHETER, MODIFICATION (K940868)Cordis Corp.1994-07-12
EYECOTECH CORP (K941414)Eyecotech Corp.1994-07-12
A-DEC RADIUS 2122/2132 (K940893)A-Dec, Inc.1994-07-12
GALILEO ARTHROSCOPES (K936280)Galileo Electro-Optics Corp.1994-07-12
JIHN MEI OPTICAL CO. (K940628)Sunny Sunglasses1994-07-12
THERA COOL HOME UNIT/COOLPAC(AMBU/RESERVIOR UNITS) (K940858)Innovation Sports, Inc.1994-07-12
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Every clearance here is in the API, with alerts when new ones post.