Atlas FDA

1991

4,235 FDA 510(k) clearances · Clearance year

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RecordFirmDate
STANDARD BREAST BOARDS; DELUXE BREAST BOARD (K905007)Bionix Development Corp.1991-02-12
ALOKA 680 DIAGNOSTIC ULTRASOUND SCANNING SYSTEM (K905252)Ge Medical Systems Information Technologies1991-02-12
VIBRONICS AUTO CORE BIOPSY DEVICE (ACBD) (K904987)Vibronics1991-02-11
PLAYTEX NON-DEODORANT AND DEODORANT TAMPONS (K905378)Playtex Family Products, Inc.1991-02-11
MAGNETOM SP/AS (ACTIVELY SHIELDED) (K905366)Siemens Medical Solutions USA, Inc.1991-02-11
STERILE DISPOSABLE SURGICAL DRAPE/ABDOMINAL DRAPE (K905466)Angiosystems, Inc.1991-02-11
AUTO SUTURE MODIFIED ENDO STREAM SUC./IRRI. DEVICE (K905426)United States Surgical, A Division of Tyco Healthc1991-02-11
ULTRASOUND COUPLING GEL (K904418)Geno Laboratories1991-02-11
HEMASTIX REAGENT STRIPS (K905396)Heraeus Kulzer, Inc.1991-02-11
IFSA STERILE BRAIDED POLY NONABSOR SURG SUTURES (K905285)Internacional Farmaceutica, S.A. DE C.V.1991-02-11
AB-TROL II COAGULATION CONTROL PLASM CAT. NO. 5183 (K905673)Helena Laboratories1991-02-11
AUTO SUTURE ENDOSCOPIC TA SURGICAL STAPLER (K910192)United States Surgical, A Division of Tyco Healthc1991-02-11
ACCU-TEC SYSTEM FOR TISSUE EXPANDER INJECTION PORT (K905484)Mentor Corp.1991-02-11
IFSA STERILE NLYLON MONOFIL NONABSOR SURG SUTURES (K905286)Internacional Farmaceutica, S.A. DE C.V.1991-02-11
PVC ROUND WOUND DRAINS (K905422)Axiom Medical, Inc.1991-02-11
CENTAURI (K905141)Pfizer Laser Systems1991-02-11
BIOVISION ENDOCULAR PROBE (K905115)Douglas James Donaldson Compliance Services1991-02-11
IFSA STERILE SILK BRAIDED NONABSOR SURG SUTURES (K905287)Internacional Farmaceutica, S.A. DE C.V.1991-02-11
DUAL LUMEN 5 FR PERIP CENT VEN CATH W/GROSHONG VAL (K904558)Davol, Inc.1991-02-11
COBE CENTRYSYSTEM 3 BICART OPTION KIT (K905388)Cobe Laboratories, Inc.1991-02-11
PLEUR-EVAC CHEST DRAINAGE SYSTEMS (K905768)Deknatel, Inc.1991-02-11
UST-2266U-5 CW DOPPLER TRANSDUCER (K905369)Ge Medical Systems Information Technologies1991-02-11
STERILE DISPOS SURGICAL DRAPE/C-SECTION DRAPE (K905465)Angiosystems, Inc.1991-02-11
CASTABLE ABUTMENTS (K900694)Calcitek, Inc.1991-02-11
BAERVELDT GLAUCOMA IMPLANT (K905129)Wright Medical Corp.1991-02-11
MEDTRONIC MODEL 3487A PISCES-QUAD LEAD (K910199)Medtronic Vascular1991-02-11
AQUA-GARD WATERPROOF WOUND PATCH (K905022)Bellhouse Medical, Inc.1991-02-11
SCIMD 7 FR. TRIGUIDE GUIDING CATHETER (K905499)Scimed Life Systems, Inc.1991-02-11
SCIMED OPTAMUM OPER PERIPHERAL ANGIOPLASTY CATH (K910155)Scimed Life Systems, Inc.1991-02-07
ANTIMICROBIAL SUSCEPT TEST PANEL/ADD ANTIBIOTICS (K904689)Alamar Biosciences Laboratory, Inc.1991-02-07
ALTAIR (K905072)Pfizer Laser Systems1991-02-07
VENTREX COATED TUBE IGE ENZYME IMMUNOASSAY (K905636)Ventrex Laboratories, Inc.1991-02-07
BARD UTERINE MANIPULATOR (K904079)C.R. Bard, Inc.1991-02-07
DIGITAL THERMOMETER KITS (K905025)Abco Dealers, Inc.1991-02-07
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL (K905853)Alamar Biosciences Laboratory, Inc.1991-02-07
MTP TRANSPORT INFUSION PUMP MODEL NO. 1001A (K905251)Medical Technical Products1991-02-07
FLO-RESTER(R) VESSEL SIZER (K905159)Bio-Vascular, Inc.1991-02-07
THE WONDER BOX (K901797)Micro Tronics Corp.1991-02-07
SWAN-GANZ(R) FLOW DIRECT OXIMETRY/THERMOD CATHER (K905458)Baxter Healthcare Corp1991-02-07
CONTAIN(TM) (K895859)Arbor Technologies, Inc.1991-02-07
ABBOTT VISION(TM) GLYCATED HB (K904027)Abbott Laboratories1991-02-07
CANMED 451 (K905729)Andover Medical, Inc.1991-02-07
WEP-8430A TELEMETRY CENTRAL STATION (K904696)Nihon Kohden America, Inc.1991-02-07
VESSELOOPS (K905240)Sparta Surgical Corp.1991-02-06
ACA(R) LACTIC DEHYDROGENASE ISOENZYME 1 (LD1) METH (K905861)E.I. Dupont DE Nemours & Co., Inc.1991-02-06
STERILE DISPOSABLE DRAPE/OPHTHALMIC SURGERY (K905460)Angiosystems, Inc.1991-02-06
PROCEDURE TRAY/FOR VARIOUS OPHTHALMIC PROCEDURES (K905462)Angiosystems, Inc.1991-02-06
A PHYSIOTHERAPY APPARATUS (K902803)Grace River Ent., Inc.1991-02-06
SENSIDERM (K904244)Ansell Intl.1991-02-06
INSTRUMENT MAKAR GRAVITY ASSIST SYSTEM (K905365)Instrument Makar, Inc.1991-02-06
SKIN MARKER (K905143)Aesculap, Inc.1991-02-06
INTERPORE CYLINDRICAL HEX IMPLANT (K904611)Interpore Intl.1991-02-05
PALMAZ BILIARY STENT (K905720)Johnson & Johnson Interventional Systems1991-02-05
CUP OUT (K905027)Anspach Mfg., Inc.1991-02-05
SOFTOUCH GUIDING CATHETER (K905547)Mallinckrodt Medical1991-02-05
MEDITRONIC ANDOVER MEDICAL MODEL 1690 ELECTRODE (K905446)Medtronic Andover Medical, Inc.1991-02-05
PHILIPS MODEL S47 BTE HEARING AID (K910206)Philips Hearing Instruments Co.1991-02-05
ARTRAC VITAL SIGNS MON. MODELS 7000 AND 5000 & ACC (K904088)Sentinel1991-02-05
MINNILERT AIR DETECTOR (K904992)Minntech Corp.1991-02-05
SUNGLASSES (K905041)Eskco, Inc.1991-02-05
SONICAID MODEL MERIDIAN 800 (K902690)Oxford Medilog, Inc.1991-02-05
CARDIOPULMONARY BYPASS VASCULAR CATHETER (K905224)3M Health Care, Sarns1991-02-05
STS(TM) FLUOROSCOPIC IMAGING MODULE (K905278)Medstone Intl., Inc.1991-02-04
ELECTRAPETTE (R) (K910140)Matrix Technologies Corp.1991-02-04
GAMMA 600 NUCLEAR MEDICINE COMPUTER (K903469)Strichman Medical Equipment, Inc.1991-02-04
KODAK EXTACHEM CLINICAL CHEMISTRY SLIDES (FE) (K910143)Eastman Kodak Company1991-02-04
.010 HI-TORQUE FLOPPY GUIDE WIRE W/PRESHAPED TIP (K905502)Advanced Cardiovascular Systems, Inc.1991-02-04
LUMATAG(R) FSH CHEMILUMINESCENCE IMMUNOMETRI ASSAY (K905814)London Diagnostics, Inc.1991-02-04
SAPPHIRE SERIES 1P, 1L, 2L, AND 2ME (K903731)Teca, Inc.1991-02-04
ABUSCREEN(R) ONLINE CALIBRATORS (K905828)Roche Diagnostic Systems, Inc.1991-02-04
ABUSCREEN ONLINE OPIATES CALIBRATORS (K910087)Roche Diagnostic Systems, Inc.1991-02-04
NIDEK DC-3000 DIODE LASER PHOTOCOAGULATOR (K903639)Nidek, Inc.1991-02-04
BIOTROL BILIRUBIN C & T CONTROL (K905280)Biotrol, USA, Inc.1991-02-04
CIBA CORNING ACS LH IMMUNOASSAY (K910198)Ciba Corning Diagnostics Corp.1991-02-04
OLYMPUS URINE PH (K905146)Diagnostic Systems1991-02-04
CONTORNO(R), MODELS E AND ST (K905108)Palex Intl. SA1991-02-04
SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-2400 (K903941)Shimadzu Medical Systems1991-02-04
MONTGOMERY(R) TAPERED SAFE-T-TUBE(TM) (K903876)Boston Medical Products, Inc.1991-02-04
EMIT CONVENIENCE PACK, QUINIDINE ASSAY/CALIBRATORS (K904990)Syva Co.1991-02-04
OPUS T3 TEST SYSTEM (K905410)Pb Diagnostic Systems, Inc.1991-02-04
HERPES SIMPLEX VIRUS TISSUE CULTURE CONF. TYPING (K904095)California Integrated Diagnostics, Inc.1991-02-01
USCI SATIN FINISH SOFT TIP ANGIOGRAPHIC CATHETER (K905727)C.R. Bard, Inc.1991-02-01
SEXTON CYSTOTOMY URINE PUMP (SCUP2) (K904434)Phoenix Bioengineering, Inc.1991-02-01
FIRM MASTER (K905195)Bak Medical Products1991-02-01
VASCULAR RETRIEVAL FORCEPS (K902999)Cook, Inc.1991-02-01
MODEL 3487A PISCES-QUAD,3587A RESUME,3586 RESUME (K905407)Medtronic Vascular1991-02-01
SARNS INVENT CATHETERS (K905638)3M Health Care, Sarns1991-02-01
MAXI-FLOW SUCTION SET W/Y CONNECTOR (K910171)Adler Instrument Co.1991-02-01
MICREL LTD PORTABLE INFUSION MICROPUMP (K903571)Technology Transfer Intl., Inc.1991-02-01
CATALOG NO. 6000-21 VOLUME NECK COIL, MODIFICATION (K905858)Medical Advances, Inc.1991-02-01
ERCP CANNULA (K905714)Everest Medical Corp.1991-02-01
MAXI-FLOW SUCTION SET 12 FT. (K910170)Adler Instrument Co.1991-02-01
IMMULITE (TM) TOTAL T3 (K905214)Cirrus Diagnostics, Inc.1991-02-01
MAGNETIC RESONANCE DIAG. DEV. SPECIAL PURPOSE COIL (K905615)Siemens Medical Solutions USA, Inc.1991-02-01
TMP LEFT ATRIAL PRESSURE CATH CAT.# 100-00X-000 (K904491)Lifestream Int'L, Inc.1991-02-01
MODEL 5866-37M LEAD ADAPTOR KIT (K904575)Medtronic Vascular1991-02-01
DIAVENTIONAL CATHETER (K905297)Cordis Corp.1991-02-01
LIFE O2 (K910201)Life Corp.1991-02-01
TEMP MARQ(TM) CONVECTIVE WARMING SYSTEM (K904690)Marquest Medical Products, Inc.1991-02-01
KINETIC AMYLASE DETERMINATION (K905651)Biochemical Trade, Inc.1991-01-31
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Every clearance here is in the API, with alerts when new ones post.