Atlas FDA

1988

4,299 FDA 510(k) clearances · Clearance year

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RecordFirmDate
FRANTZ MEDICAL SHARPS COLLECTOR (K884589)Franklin Medical USA, Inc.1988-12-09
SURGEON'S GLOVE ACCESSORY (K884417)Allied Signal, Inc.1988-12-09
QUALTEX NEUROLOK SURGICAL SPONGE (K884790)Deroyal Industries, Inc.1988-12-09
MODIFIED LSF TOTAL HIP SYSTEM (K884432)Implant Technology, Inc.1988-12-09
ROCHE REAGENT FOR CHLORIDE (K884013)Roche Diagnostic Systems, Inc.1988-12-09
STERILE DISPOSABLE ENDOCULAR PROBE (K884456)Biophysic Medical, Inc.1988-12-09
IDS-1600 SAMPLE HANDLING SYSTEM (K883470)Baxter Healthcare Corp1988-12-09
CALIBRATOR STANDARD KIT FOR ASTRA SYSTEM (K884227)A-Kem, Inc.1988-12-09
TROJAN EXTRA STRENGTH LUBRICATED (K883413)Carter Products1988-12-08
BAXTER DISPOSABLE CIRCUMCISION TRAY (K884290)Baxter Healthcare Corp1988-12-08
MARTIN-CHAMPY TITAN SET (K884523)Buschmann Surgical Products1988-12-08
CRYSTAR(TM) VINTAGE PORCELAIN (K884214)Shofu Dental Corp.1988-12-08
TRANSENDOSCOPIC ASPIRATION NEEDLE (K883093)Endovations1988-12-08
ODOR-END EMERGENCY CLEAN UP POWDER (K882878)Cdc Products Corp.1988-12-08
PACING LEADS FOCUS T81,T81F,T82F,T83,T83F,T84F (K884394)Ela Medical, Inc.1988-12-08
BLOOD TUBING SET (K884243)Mediflex Intl.1988-12-08
COOK HYSTEROCATH(TM) (K884291)Cook, Inc.1988-12-08
TECHMEDICA I.B.O. BLADE (K883922)Techmedica, Inc.1988-12-08
MULTIFLOW(TM) 60 KIT (K884365)Hospal Medical Corp.1988-12-08
DELIVERY PUMP FOR STERILE IRRIGANT & HANDPIECE DR. (K882526)Aseptico, Inc.1988-12-08
IMPRA DUAL LUMEN SUBCLAVIAN - FEMORAL CATHETER (K883592)Impra, Inc.1988-12-08
MODIFIED SANDERS BI-PAPEASY (K883825)Respironics, Inc.1988-12-08
NH PEDIATRIC REPLACEMENT GASTROSTOMY KIT (K884309)Biosearch Medical Products, Inc.1988-12-08
LAKE N/G EXTENSION SET (K884128)Lake Medical Products, Inc.1988-12-08
ULTRX(TM) 850 ARTIFICIAL KIDNEY (K884353)Cd Medical, Inc.1988-12-08
MODIFIED L.J.'S SEX HELPER (K882531)L.J. Fant & Co.1988-12-08
PREEMICARE MODEL D1-X1, SERIES 3000 (K881476)Preemicare Corp.1988-12-08
MODIFIED IDEIA CHLAMYDIA TEST (K880799)Boots-Celltech Diagnostics, Inc.1988-12-08
RETRACTABLE NEEDLE 3CC SYRINGE (K881454)Kenmar Medical1988-12-08
TASSI MK2 (K884835)Therapy Air Support Systems, Inc.1988-12-07
FIBERLITE, FIBERLITE HS AND FIBERSEAL (K884038)Jeneric/Pentron, Inc.1988-12-07
MODIFIED SAW BLADES TO THE SAGITAL SAW (K884839)Dyonics, Inc.1988-12-07
APOLLO VS, VT, VR 1000/1500, FREEDOM HS, HT, HR (K883904)Apollo Dental Products, Inc.1988-12-07
OTOMETER PORTABLE SCREENING AUDIOMETER (K883169)Otometer, Inc.1988-12-07
MIRAGE BOND (K884137)Chameleon Dental Products, Inc.1988-12-07
GV3000 PHACOEMULSIFIER/FRAGMENTER (K883097)D.O.R.C. Intl. B.V.1988-12-06
BECKMAN LAMBDA LIGHT CHAIN REAGENT (K884597)Beckman Instruments, Inc.1988-12-06
ABBOTT A-GENT LIPASE REAGENT (K884596)Abbott Laboratories1988-12-06
UNIVERSAL GENERATOR IRRIGATOR MODEL UGI-3000 (K884836)Meditron Devices, Inc.1988-12-06
CIBA CORNING MAGIC LITE FSH IMMUNOASSAY (K884687)Ciba Corning Diagnostics Corp.1988-12-06
LANDMARK VENOUS ACCESS DRIVE (ADDITIONAL SIZES) (K883980)Menlo Care, Inc.1988-12-05
TEMPOROMANDIBULAR JOINT COIL (TMJ) (K884743)Diasonics, Inc.1988-12-05
ENDOCARDIAL PACING LEADS-ANCHORING SLEEVE MODIFIED (K884005)Medtronic Vascular1988-12-05
FLEXIBLE MYOCARDIAL BIOPSY FORCEPS (K883723)Cook, Inc.1988-12-05
SYSMEX NE-8000 (K883997)Toa Medical Electronics USA, Inc.1988-12-05
RUBEOLA TEST (K884004)Gull Laboratories, Inc.1988-12-05
FILTRAL TM 8 HEMODIALYZER (K884326)Hospal Medical Corp.1988-12-05
MODIFIED CELL-MATICS HERPES SIMPLEX VIRUS DETECT. (K884761)Difco Laboratories, Inc.1988-12-05
MAXITHINS REGULAR PADS, DEODORANT (K884444)Tambrands, Inc.1988-12-05
INDIRECT FLUORESCENT ASSAY FOR (HCMV) (K882835)Stellar Bio Systems, Inc.1988-12-05
ENCOR UNIPOLAR VS-1 LEADS (K883070)Cordis Leads, Inc.1988-12-05
GASTROSTOMY FEEDING DEVICE (K884439)Southside Biotechnology1988-12-05
IONODENT II (6 VOLTS) (K883761)U.S. Apatite Corp.1988-12-05
OMRON ULTRASONIC NEBULIZER NE-U06 (K875134)Nidek, Inc.1988-12-05
SARNS MP4 CARDIOPLEGIA DELIVERY SYSTEM (K883071)3M Health Care, Sarns1988-12-05
POLYCORD II (K880303)Technetics, Inc.1988-12-05
IMMUKNOW-CHECK HCG ASSAY KIT, CAT. #900-40 (K883148)Diagnostic Chemicals, Ltd. (Usa)1988-12-05
PROSTATIC CORE-CUT NEEDLE (K883884)Euro-Med Intl.1988-12-05
CHRONAMED CM101 (K881206)Chronamed Corp.1988-12-05
HILL NASOGASTRIC TUBE (K883319)Zinetics Medical, Inc.1988-12-05
BLOOD RESERVOIR, CARDIOPULMONARY BYPASS (K882414)Gish Biomedical, Inc.1988-12-05
INTERSEPT* PREBYPASS FILTER (K884244)Medtronic Blood Systems, Inc.1988-12-05
MT/S (SPINE TRANSMIT COIL) (K884606)Diasonics, Inc.1988-12-05
CHRONODYNAMICS DATA RECORDER (CDR)-100 (K881813)Chronodynamics, Inc.1988-12-05
SYSTEM VI MONITOR (K874326)Air-Shields, Inc.1988-12-05
CHELON-FIL (K884475)Espe GmbH (Us)1988-12-05
HEMAT 12 (K884006)Texas Intl. Laboratories, Inc.1988-12-05
ISO-100 ISOLATION AMPLIFIER (K883947)Telediagnostic Systems, Inc.1988-12-05
KIM NASO-INTESTINAL TUBE (K882918)Sheridan Catheter Corp.1988-12-05
MAXITHINS PANTY SHIELDS, DEODORANT (K884445)Tambrands, Inc.1988-12-05
USCI TANDEM ADAPTER (K884200)C.R. Bard, Inc.1988-12-05
KLEIN HANDLE (K881783)E.L. Medico Intl., Inc.1988-12-02
HEXASCAN HANDPIECE FOR ARGON/DYE LASER (K884431)California Laboratories, Inc.1988-12-02
MODIFICATION OF THE CEDIA DIGOXIN ASSAY (K884054)Microgenics Corp.1988-12-02
CUSA SYSTEM 200H ULTRASONIC SURGICAL ASPIRATOR (K884413)Valleylab, Inc.1988-12-02
ALWAYS UNSCENTED MENSTRUAL PADS (K884428)Procter & Gamble Co.1988-12-02
RESUBMITTED ABBOTT TESTPACK(TM) HCG COMBO (K884207)Abbott Laboratories1988-12-02
MODIFIED LOW-TEMP. FREEZER MODEL HLT-80LS-85 (K884436)Harris Mfg. Co.1988-12-02
KLEIN NEEDLE (K881784)E.L. Medico Intl., Inc.1988-12-02
NOVA STAT PROFILE 7 ANALYZER QUALITY CONTROL MATER (K884143)Nova Biomedical Corp.1988-12-02
TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY (K884085)Hybritech, Inc.1988-12-02
ALWAYS SCENTED OR SCENTED DEODORIZED MENSTRUAL PAD (K884429)Procter & Gamble Co.1988-12-02
CONFIDENCE(TM) STERILE, DISP., LATEX SURG. GLOVES (K882431)Charise Charles, Ltd.1988-12-02
CUSA SYSTEM 200C,T & M ULTRASONIC SURGICAL ASPIRA. (K884412)Valleylab, Inc.1988-12-02
VISION LYTE (TM) POTASSIUM (K884566)Abbott Laboratories1988-12-02
INTRODUCING CATHETER (K883933)Devices For Vascular Intervention, Inc.1988-12-02
INTERIM, TEMPORARY CEMENT (K884081)Scientific Pharmaceuticals, Inc.1988-12-02
DELFIA TRIIODOTHYRONINE (T3) KIT (K883810)Pharmacia, Inc.1988-12-02
BIO-TEK AUTOMATED MICROPLATE WASHER MODEL EL403 (K884125)Bio-Tek Instruments, Inc.1988-12-02
SAFE-TEC CAPILLARY BLOOD COLLECTION TUBE (K884623)Safe-Tec Clinical Products, Inc.1988-12-01
INTERLOCKING INTRAMEDULLARY NAILS (K884610)Depuy, Inc.1988-12-01
CORDEX SHAVER, BLADES, RECHARGER AND BATTERIES (K882469)Orthoconcept, Inc.1988-12-01
EXCEL INFLATE-AID (K883769)Medical Profiles, Inc.1988-12-01
AMK TOTAL KNEE SYSTEM WITHOUT POROCOAT (K883122)Depuy, Inc.1988-12-01
ACUSON L538 TRANSDUCER (K883752)Acuson Corp.1988-12-01
TENDERFOOT (K883968)International Technidyne Corp.1988-12-01
ADD-ON TO CRITICAL PATIENT CARE BED (K882177)Cardio Systems, Inc.1988-12-01
SHOWER CHAIR (K884760)Linido, Inc.1988-11-30
ZIMMER BEADED THREADED ACETABULAR CUP (K884658)Zimmer, Inc.1988-11-30
CONVA-LIFT (K882406)Numerical Concepts, Inc.1988-11-30
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Every clearance here is in the API, with alerts when new ones post.