Atlas FDA

1996

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

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RecordFirmDate
PROSYS BEDSIDE DRAINAGE BAG (STERILE) MODEL 650167 (K960949)Bristol-Myers Squibb1996-04-19
RELISA SM/RNP ANTIBODY TEST SYSTEM (K955604)Immuno Concepts, Inc.1996-04-19
RDI CARDIAC INSULATION PAD (K960312)R D Intl.1996-04-19
G.E. STERILE ANGIOGRAPHIC TRAY (K960139)GE Medical Systems1996-04-19
SARNS 9000 UNIVERSAL ROLLER PUMP (K953904)3M Health Care, Ltd.1996-04-19
RELSIA SCL-70 ANTIBODY TEST SYSTEM (K955602)Immuno Concepts, Inc.1996-04-19
SARNS 800 ROLLER PUMP (K953901)3M Health Care, Sarns1996-04-19
RELSIA SS-A/RO & SS/B LA ANTIBODY TEST SYSTEM (K955603)Immuno Concepts, Inc.1996-04-19
CRP-LATEX SEIKEN XR REAGENT SYSTEM (K960702)Globe Management Support, Inc.1996-04-19
PEC IMPLANT (K961072)Rand Scientific Corp.1996-04-19
PATHROMTIN SL (K955450)Behring Diagnostics, Inc.1996-04-19
RELISA JO-1 ANTIBODY TEST SYSTEM (K955605)Immuno Concepts, Inc.1996-04-19
MEDIAL MALAR IMPLANT (K961080)Rand Scientific Corp.1996-04-19
HEBELER SAFE-T-TUBE (K960450)Boston Medical Products, Inc.1996-04-19
RF-LATEX SEIKEN REAGENT SYSTEM (K960703)Globe Management Support, Inc.1996-04-19
PHASE CONJUGATE SYMMETRY OPTION FOR OUTLOOK (K960294)Philips Medical Systems (Cleveland), Inc.1996-04-19
THE NAUTILUS (K961124)Rand Scientific Corp.1996-04-19
RUSCH OPTOSAFE (K960240)Rusch Intl.1996-04-19
WEBB-MORLEY SPINE SYSTEM (K960451)Buckman Co., Inc.1996-04-18
ORGENTEC ANTI-SCL 70 PIN IMMUNO ASSAY (K954814)Orgentec1996-04-18
OSTEOGRAFT/N-700 HYDROXYLAPTITE (K960368)Ceramed Corp.1996-04-18
LM BONE ANCHOR (K960439)Li Medical Technologies, Inc.1996-04-18
SURGICAL APPAREL (K954549)Global Healthcare, Inc.1996-04-18
ORGENTEC ANTI-JO-1 PIN IMMUNO ASSAY (K954829)Orgentec1996-04-18
ENDOSCOPE INTRODUCER KIT (K955717)Mitsubishi Cable America, Inc.1996-04-18
AM 400 (K961084)Electone, Inc.1996-04-18
PERINEOMETER (K960311)Hollister, Inc.1996-04-18
PROV-KB (K960938)Silicon-Und Composite Spezialitaten GmbH1996-04-18
OSTEOGRAF/LD-300 HYDROXYLAPATITE (K960353)Ceramed Corp.1996-04-18
ORGENTEC ANTI-SS-A(RO) PIN IMMUNO ASSAY (K954815)Orgentec1996-04-18
ORGENTEC ANTI-SS-B(LA) PIN IMMUNO ASSAY (K954832)Orgentec1996-04-18
UNIVEC NON-REUSABLE SYRINGE (K933469)Univec, Inc.1996-04-18
OMIN-TRAK MODEL 3500 SERIES PATIENT MONITORING SYSTEM (K950688)Safety Tek Corp.1996-04-18
MOLLOY INTUBATING STYLETTE (K943104)Molloy Corp.1996-04-18
DRS 4 DIALYZER REPROCESSING SYSTEM (K931336)Seratronics, Inc.1996-04-18
M. CAT BUTYRATE DISK (K960996)Hardy Diagnostics1996-04-18
ARGEDENT 40(GOLD-PALLADIUM-SILVER ALLOY FOR PORCELAIN APPLICATION) (K961285)Argen Precious Metals, Inc.1996-04-18
WHITE RIVER BATTERY-POWERED BREAST PUMP (K952712)Natural Technologies, Inc.1996-04-18
FASTAK SUTURE ANCHOR (K960516)Arthrex, Inc.1996-04-18
IMMUNOCARD TOXIN A (K955859)Meridian Diagnostics, Inc.1996-04-18
MODULAR ONCOLOGY SYSTEM TECHNOLOGY (MOST) (K960626)Intermedics Orthopedics1996-04-18
LM ANCHOR (K960448)Li Medical Technologies, Inc.1996-04-17
ACCU-CHEK INSTANT PLUS G-C/DM BLOOD GLUCOSE MONITORING SYSTEM (K944459)Boehringer Mannheim Corp.1996-04-17
KODAK DIGITAL SCIENCE MEDICAL IMAGE MANAGER (K960382)Eastman Kodak Company1996-04-17
TAMPAX TAMPON WITH ADDITIVE JUNIOR,REGULAR,SUPER, AND SUPER PLUS (K960341)Tambrands, Inc.1996-04-17
AREMA II (K961129)Mellen Air Mfg., Inc.1996-04-17
MEDI-JECT CORPORATION MEDI-JECTOR NEEDLE-FREE BIO-TROPIN DDRUG DELIVERY SYSTEMS 0.0058/0.0068(INCH DIAMETER NOZZLEORIFIC (K960285)Medi-Ject Corp.1996-04-17
INTRACAVITY TRANSDUCERS (K953716)Biosound, Inc.1996-04-17
CAREFREE PANTYLINERS (K961119)Personal Products Co.1996-04-17
IMAGEFUSION (K960071)Radionics Software Applications, Inc.1996-04-17
WHATMAN BODY FLUID COLLECTION PAPER:WHATMAN BFC180 (K932661)Whatman Specialty Products, Inc.1996-04-17
USCI IDEAL PTCA KIT (K953522)Ryder Intl. Corp.1996-04-17
CELSITE PEDIATRIC VENOUS SYSTEM (K952435)B.Braun Medical, Inc.1996-04-17
AT53 DUAL CHANNEL EMG (K952797)Stoelting Co.1996-04-17
STORC INTRAUTERINE PRESSURE CATHETER (K954955)Clinical Innovations, Inc.1996-04-17
CODAN MEDLON BC110 VIAL ADAPTER CODAN SPIKE (K960921)Codan Medlon, Inc.1996-04-17
EVOKED POTENTIAL SYSTEM-1.0 (K932994)Neuromedical Systems, Inc.1996-04-15
CORING MORCELLATOR (K960262)Cook Urological, Inc.1996-04-15
GUTHRIE POWDERFREE LATEX EXAMINATION GLOVES (K954967)Guthrie Medicare Products (Melaka) Sdn Bhd1996-04-15
RUBELLA IGG ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC DEVICE (K951359)Bayer Corp.1996-04-15
CU-200 LIGHT CURE UNIT (K960364)Rolence Enterprise Co. , Ltd.1996-04-15
CARBOMEDICS VALVE TESTER (K960169)Carbomedics, Inc.1996-04-15
THYROCHEK ONE-STEP RAPID TSH ASSAY (K960195)Franklin Diagnostics, Inc.1996-04-15
Q-LUX LIGHT CURE UNIT (K960351)Rolence Enterprise Co. , Ltd.1996-04-15
CAROLINA NARROW FABRIC COMPANY CLOSED TOE ANTI-EMBOLISM STOCKING (K961177)Carolina Narrow Fabric Co.1996-04-15
FOUNDATION GLENOID COMPONENT (K960906)Encore Orthopedics, Inc.1996-04-15
PERMAMESH-D HYDROXYLAPATITE MATRIX (K960361)Ceramed Corp.1996-04-15
G.E. STERILE CT BIOPSY TRAY (K960144)GE Medical Systems1996-04-15
CARDS Q.S. STREP A (K955108)Quidel Corp.1996-04-15
PLATINUM SERIES EP DIAGNOSTIC CATHETERS (K953185)Medtronic Cardiorhythm1996-04-15
NON-CORING NEEDLE (K960698)Med Institute, Inc.1996-04-15
TMP MANDIBULAR COMPRESSION SYSTEM (MODIFICATION) (K960514)Anspach Fixation Systems1996-04-15
HYDROSPOT EEG ELECTRODE MODEL 1501, HYDROSPOT LEADWIRE MODEL 1500 (K960732)Physiometrix, Inc.1996-04-15
POWERS ANTI-BACTERIAL VALVE (K954471)Powers Dental & Medical Technology, Inc.1996-04-15
AUSONICS OPUS 2 REALTIME ULTRASOUND SCANNER (K945957)Kleinfeld, Kaplan and Becker1996-04-15
POWDER FREE TACTYLON SURGEONS GLOVE (K955419)Tactyl Technologies, Inc.1996-04-15
THERAPORT VASCULAR ACCESS SYSTEM; MODEL 1001, 1002, 1601, 1602 (K960350)Biocontrol Technology, Inc.1996-04-15
GORE-TEX REGENERATIVE MATERIAL TITANIUM REINFORCED CONFIGURATIONS (K960292)W. L. Gore & Associates, Inc.1996-04-15
ENTERALITE (K954735)Zevex Intl., Inc.1996-04-15
D.O.R.C. VFI/VFE SYSTEM (K954842)Dutch Ophthalmic USA, Inc.1996-04-15
DENTO-SURGE (K955176)Ellman Intl., Inc.1996-04-15
INNOVA RECTAL STIMULATON ELECTRODE (K954272)Empi1996-04-15
REAL-TIME RECONSTRUCTION SYSTEM MODEL TSXF-001A (K950972)Toshiba America Medical Systems, In.C1996-04-15
EXPANDED BODY SUTURE (K961025)Medicinelodge, Inc.1996-04-15
CPR SUCTION CATHETER KIT (K960216)Custom Pack Reliability1996-04-15
NOGA (K960542)Biosense, Ltd.1996-04-15
OLYMPUS EU-M30 ENDOSCOPIC ULTRASOUND CENTER (K951994)Olympus America, Inc.1996-04-15
OEC 902, 901 NASA II, OEC 902, 901 NASA I CCD C-ARM (K955251)Imaging Services, Inc.1996-04-12
CPR TOTAL HIP PACK (K960213)Custom Pack Reliability1996-04-12
RTI MEDICAL (K954567)Radiology Telenetwork Intl.1996-04-12
FLOWMATE LTE (K954759)Spirometrics Medical Equipment Co.1996-04-12
BIOSENSOR BIDOP VASCULAR TEST SYSTEM (K943338)Biosensor Corp.1996-04-12
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY (K954353)General Electric Co.1996-04-12
BRAUN HEMOSTASIS INTRODUCERS (K960406)B.Braun Medical, Inc.1996-04-12
CPR TOTAL KNEE PACK (K960211)Custom Pack Reliability1996-04-12
SECOND EAR BONE CONDUCTION HEARING AID (K953872)Wordcomp International Communication Group (Wicg)1996-04-12
GENERAL PROCEDURE KIT (K960248)Physician Industries, Inc.1996-04-12
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY (K954354)General Electric Co.1996-04-12
CPR ORTHO HAND PACK (K960210)Custom Pack Reliability1996-04-12
CPR DRESSING CHANGE TRAY (K960206)Custom Pack Reliability1996-04-12
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Track 1996 automatically

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