Atlas FDA

1989

5,030 FDA 510(k) clearances · Clearance year

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RecordFirmDate
RESUBMITTED ABBOTT LIFECARE MODEL 3 HB PUMP (K890282)Abbott Laboratories1989-04-19
POROUS COATED GENESIS FEMORAL COMPONENT (K885036)Richards Medical Co., Inc.1989-04-19
SYSTEM SEVENTY SEVEN (K885054)Scinticor, Inc.1989-04-19
VITAL SIGNS MONITOR (K884938)Tico Medical Instruments, Inc.1989-04-19
HEPARIN BONDING FOR CATHETERS (K884697)Daig Corp.1989-04-19
TITANIUM STAPLES (K890841)ETHICON, Inc.1989-04-19
UNI-KNEE COMPONENT OF THE NATURAL-KNEE SYSTEM (K883969)Intermedics Orthopedics1989-04-19
PHOTOCHROMIC LENS (K890725)Ppg Industries, Inc.1989-04-19
EXCEL Y-CONNECTOR CAT. #E-201 (K884327)Medical Profiles, Inc.1989-04-19
COATED APEX PROBE (K890735)Analytic Technology1989-04-19
CAM-WRAP(TM) NEW STERILIZATION PROCEDURE (K891983)Medical Dynamics, Inc.1989-04-19
LIPID STOPCOCK (K890580)North American Instrument Corp.1989-04-19
KINETIC MODEL 500 (K891756)Kinetic Biomedical Services, Inc.1989-04-19
NOSEY SHADES (SUNGLASSES) NONPRESCRIPTION (K891597)Creative Images, Inc.1989-04-19
KINETIC MODEL 330 (K891759)Kinetic Biomedical Services, Inc.1989-04-19
KINETIC MODEL 132 (K891758)Kinetic Biomedical Services, Inc.1989-04-19
KINETIC MODEL 1000 (K891757)Kinetic Biomedical Services, Inc.1989-04-19
CD TELEMETRY SYSTEMS (K891104)Marquette Electronics, Inc.1989-04-19
HORIZON 2000 ARRHYTHMIA MONITOR OPTION - (ALARMS) (K885204)Mennen Medical, Inc.1989-04-19
CARERITE FACE MASK (K891141)Cost Rite Health Products, Inc.1989-04-18
IRON REAGENT (K891155)Medical Analysis Systems, Inc.1989-04-18
HEMAWIPE SYSTEM, THE CIVILIZED TEST (K884206)Labeltape Meditect, Inc.1989-04-18
DIRECTIGEN1-2-3 BHCG PREGNANCY TEST (K890615)Quidel Corp.1989-04-18
CELL-DYN 3000 MULTI-PARAMETER HEMATOLOGY ANALYER (K890491)Abbott Diagnostics1989-04-18
MERIT INTELLIFLATOR(TM) & MERIT MONITOR(TM) (K884913)Merit Medical Systems, Inc.1989-04-18
PATIENT EXAMINATION GLOVE (K890976)Cranberry (M) Sdn. Bhd.1989-04-18
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) (K891385)Vitek Systems, Inc.1989-04-18
CORE BIOPSY NEEDLE, CATALOG CODE #54006 (K891537)Dlp, Inc.1989-04-18
HI CHEM INORGANIC PHOSPHORUS REAGENT KIT #88196 (K890773)Hichem Diagnostics1989-04-18
MARDX LYME DISEASE IGG IFA TEST SYSTEM (K890053)Mardx Diagnostics, Inc.1989-04-18
3MM DISPOSABLE SPECULA (K891589)Semantodontics, Inc.1989-04-18
SUTURE REMOVAL KIT (K890729)Cypress Medical Products, Ltd.1989-04-17
FLUOREVER(R) DUAL CURE CERAMIC VENEER CEMENT (K890623)Macrochem Corp.1989-04-17
BICARBONATE CONCENTRATE POWDER (K891921)Haemolyte, Inc.1989-04-17
UNIFAST LC (K890829)G-C Intl. Corp.1989-04-17
FLUOREVER(R) LIGHT CURE CERAMIC VENEER CEMENT (K890608)Macrochem Corp.1989-04-17
MENTOR ANTERIOR SEGMENT VITRECTOR (K890595)Mentor O & O, Inc.1989-04-17
BCM-ARC 105 X-RAY MOBILE UNIT (K890306)B C Medical , Ltd.1989-04-17
NEUROFOCAL COLLIMATOR (K891266)Siemens Gammasonics, Inc.1989-04-17
CLEAN DENT (K890668)Lincoln Park Dental Laboratory1989-04-17
APEX 609R ANGER CAMERA (K884675)Elscint, Inc.1989-04-17
INTERCASSETTE, INTERKIT, UNIVERSAL PAK & CASSETTE (K890300)CooperVision, Inc.1989-04-17
MODIFIED LABELING FOR POLYDERM WBC(TM) (K890940)Laivan Corp.1989-04-17
CENTURY DISOSABLE LATEX GLOVE (K890850)Century Force Co. , Ltd.1989-04-17
SURGICAL DRILLS (K891615)Implant Innovations International, Inc.1989-04-17
NON-ABSORB GAUZE SURG SPONGE & WOUND DRESS/EXT USE (K891460)Smith & Nephew United, Inc.1989-04-17
TITANIUM FORCEPS (K891618)Implant Innovations International, Inc.1989-04-17
LIP BUMPER (K890656)American Orthodontics1989-04-17
DOCTOR KOLYNOS TOOTHBRUSH (K882572)Whitehall Laboratories, Inc.1989-04-17
FRASTEC CONFORMANT DRESSING, VARIOUS SIZES (K885325)Frastec Wound Care Products, Inc.1989-04-17
APEX 415 ANGER CAMERA (K884674)Elscint, Inc.1989-04-17
DICOR CERAMIC INLAY - NEW TECHNIC (K884166)Dentsply Intl.1989-04-17
T.R.S.: TOOTH REPLACEMENT SYSTEM (K891119)Health Technology of America, Inc.1989-04-17
HEMO-CATH SILICONE DOUBLE LUMEN CATHETER (K890029)Medical Components, Inc.1989-04-17
NON-ABSORBABLE GAUZE, SURGICAL SPONGE & DRESSING (K891101)Smith & Nephew United, Inc.1989-04-17
GK ALLOY (K891390)China Link, Inc.1989-04-17
MORRIS ANTI-SPLATTER DEVICE FOR ENDOSCOPES (K884097)Circon Acmi1989-04-17
ORTHODONTIC COTTON ROLL HOLDERS (K891354)American Orthodontics1989-04-17
APEX 115 NUCLEAR MEDICINE PROCESSOR (K884672)Elscint, Inc.1989-04-17
FETAL DOPPLER FOR ULTRAMARK 4 AND 8 (K881329)Advanced Technology Laboratories, Inc.1989-04-14
EMIT CONVENIENCE PACK: THYROXINE ASSAY (K890831)Syva Co.1989-04-14
EZ COMPLEMENT C3 (K892127)Diamedix Corp.1989-04-14
APEX 215M MOBILE ANGER CAMERA (K884673)Elscint, Inc.1989-04-14
PATIENT EXAM GLOVES (LATEX) MFG. TIANJIN KANG BAO (K891740)Brilliant Ray Intl., Inc.1989-04-14
M-77 GOLD BASE DENTAL ALLOY (K891530)Macdonald Metals and Ceramics1989-04-14
TRANSCUTANEOUS O2/CO2 MONITOR (K890517)Novametrix Medical Systems, Inc.1989-04-14
SURGICAL GOWN #2001 (K891211)Pro-Safe Professional Linens, Inc.1989-04-14
BEEHIVE-64 OR BEEHIVE-32, DIGITAL EEG RECORDING (K884937)Grass-Telefactor Product Group1989-04-14
ANA-5 AUTOANTIBODY PROFILE KIT (K885224)Autoimmunity Diagnostics Corp.1989-04-14
SURGICAL INSTRUMENT POUCH #M102 (K891213)Pro-Safe Professional Linens, Inc.1989-04-14
REDI-VU MODEL RV-386 (K890397)J.D. Technical Services1989-04-14
C REACTIVE PROTEIN LIQUID (K892146)Ampcor, Inc.1989-04-14
EZ COMPLEMENT C2 (K892125)Diamedix Corp.1989-04-14
DENTAL SURGICAL WRAP #3007 A,B,C (K891214)Pro-Safe Professional Linens, Inc.1989-04-14
WANG FRONT LOADING APPLICATOR (K890485)Mick Radio-Nuclear Instruments, Inc.1989-04-14
AQUA-BLANKET HYPER/HYPOHERMIA BLANKET (K890852)Ati1989-04-14
ACCES. PACKAGE FOR USE W/CARDIOGEN-82 GENERATOR (K883609)Squibb Diagnostics1989-04-14
CESIUM 137 SOURCE, MODEL CSM-40 (K882449)Cis-Us, Inc.1989-04-14
MODEL 3031; CERVICAL SPINE SURFACE COIL (K890666)Medical Advances, Inc.1989-04-14
ORTHODONTIC WRAP-AROUND HAWLEY RETAINER (K891484)American Orthodontics1989-04-14
PATIENT EXAM GLOVE (LATEX) MFG. TIANJIN JI COUNTY (K891739)Brilliant Ray Intl., Inc.1989-04-14
PATIENT EXAMINATION GLOVES (LATEX) (K891637)Powercrest (M) Sdn. Bhd.1989-04-14
EZ COMPLEMENT C4 (K892129)Diamedix Corp.1989-04-14
C-89 GOLD BASE DENTAL ALLOY (K891516)Macdonald Metals and Ceramics1989-04-14
COMFORTRON DENTAL ANESTHESIA APPARATUS (K884586)M. D. Products1989-04-14
FAST WRAP #M 101 (K891215)Pro-Safe Professional Linens, Inc.1989-04-14
EZ COMPLEMENT C1 (K891904)Diamedix Corp.1989-04-14
QUIK-DOT C REACTIVE PROTEIN (K892119)Ampcor, Inc.1989-04-14
APRONS, SCRUBS SLACKS & TOPS, PATIENT DRAPE (K891212)Pro-Safe Professional Linens, Inc.1989-04-14
INTERSPEC APOGEE (K890173)Interspec, Inc.1989-04-14
PATIENT EXAMINATION GLOVES (LATEX) (K891636)Broadland Rubber Industries Sdn Bhd1989-04-14
H&M ANTI-SNORING DEVICE (K882303)Hays & Meade, Inc.1989-04-14
AQUA-PAD FOR MOIST OR DRY HEAT THERAPY (K890853)Ati1989-04-14
HILARIS-NORI CERVIX APPLICATOR (K891377)Mick Radio-Nuclear Instruments, Inc.1989-04-14
DEKNATEL HIGH PRECISION VASCULAR PUNCH(TM) (K890432)Deknatel, Inc.1989-04-13
PATIENT EXAMINATION GLOVES (LATEX) (K891884)Duflex Products Sdn. Bhd.1989-04-13
PENN-PET SCANNER (K890100)Ugm Medical Systems, Inc.1989-04-13
CURITY DISPOSABLE LATEX GLOVES (K891255)Kendall Healthcare Products Co. Div.Of Tyco Health1989-04-13
PATIENT EXAMINATION GLOVES (VINYL) (K891356)Pm Gloves, Inc.1989-04-13
PATIENT EXAMINATION GLOVE (LATEX) (K891112)Medglove1989-04-13
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Track 1989 automatically

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