Atlas FDA

1988

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

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RecordFirmDate
TRACHEAL TUBE LASER SHIELD KIT (K883096)Americal Corp.1988-09-08
ACUSON I7505 TRANSDUCER, ULTRASOUND TRANSDUCER (K882737)Acuson Corp.1988-09-08
OLYMPUS REPLY CHEMISTRY ANALYZER (K882451)Olympus Corp.1988-09-08
CATAPULT BUCKY (KATAPULT BLENDA) (K883160)Bay X-Ray, Inc.1988-09-08
TRANSCRAN(TM) TRANSCRANIAL PULSED DOPPLER SYSTEM (K882015)Ultramed, Inc.1988-09-08
METATECH ROBINSON BOLT ACCESSORY (K882552)Metatech Corp.1988-09-08
VAC-G (GUILLOTINE VITRECTOR) (K881519)B&B Medical Assoc., Inc.1988-09-08
RESUBMITTED UTISCREEN(TM) BACTERIAL ATP TEST (K883385)Los Alamos Diagnostics1988-09-07
SYSTEM 9000 DIFF MODEL AUTOMATED CELL COUNTER (K882612)Baker Instructions Corp.1988-09-07
UBI MAGIWEL RF-IGM QUANTITATIVE (K883355)United Biotech, Inc.1988-09-07
MICROLYTE 7 (K880973)The Rupp & Bowman Co.1988-09-07
TECHNICON DPA-1 APOLIPOPROTEIN B (K883491)Technicon Instruments Corp.1988-09-07
EX-CELL 301, CATALOG NO. 200-3651 (K883625)J R Scientific1988-09-07
EX-CELL 300TM, CATALOG NO. 200-3601 (K883624)J R Scientific1988-09-07
DHBTI-ALLERGEN IGE FASTSCREEN IV (G1,G5,G12,G13) (K883273)3M Company1988-09-07
HEMATRAK(R) MODEL 590 (K882579)Priority Service Systems1988-09-07
QM300 CALIBRATOR E PACK (K883538)Kallestad Diag, A Div. of Erbamont, Inc.1988-09-07
GRAM NEGATIVE & GRAM POSITIVE MIC/COMBO PANELS (K883076)Baxter Healthcare Corp1988-09-07
MIN ESSENT MED EAGLE FOR SPINN CULTURE, #200-2051 (K883628)J R Scientific1988-09-07
QM300 RHEUMATOID FACTOR ANTIGEN PACK (K883536)Kallestad Diag, A Div. of Erbamont, Inc.1988-09-07
GRAM NEGATIVE AND GRAM POSITIVE MIC/COMBO PANELS (K883394)Baxter Healthcare Corp1988-09-07
MIN ESSENT MED EAGLE, JOKLIK MOD, CAT. #200-2150 (K883627)J R Scientific1988-09-07
TECHNICON DPA-1 IMMUNOGLOBULIN G (K883494)Technicon Instruments Corp.1988-09-07
ACUTE PHASE C-REACTIVE PROTEIN LATEX AGGLU. TEST (K882998)Amtec Diagnostics International, Inc.1988-09-07
HANK'S BALANCED SALTS (HBSS) CATALOG # 210-3013 (K883629)J R Scientific1988-09-07
EX-CELL 300TM, CATALOG # 210-3579 (K883631)J R Scientific1988-09-07
EX-CELL 300TM, CATALOG NO. 200-3600 (K883623)J R Scientific1988-09-07
EX-CELL 300TM, CATALOG NO. 210-3575 (K883632)J R Scientific1988-09-07
HISTONE REACTIVE ANA (K883232)Val Tech Diagnostics, Inc.1988-09-07
QLIA IMMUNOCHEMISTRY SYSTEM (K883349)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-09-07
EX-CELL 301, CATALOG NO. 210-3577 (K883626)J R Scientific1988-09-07
VAC (OSCILLATING VITRECTOR) (K881520)B&B Medical Assoc., Inc.1988-09-07
RPMI-1640 MEDIUM, CATALOG NO. 210-3525 (K883630)J R Scientific1988-09-07
TELESTATIX X-RAY TABLE (K883162)Bay X-Ray, Inc.1988-09-06
SELDIX 325 TWO PULSE GENERATOR/CONTROL (K883154)Bay X-Ray, Inc.1988-09-06
EOL, MODEL LIO (K881984)Eol, Inc.1988-09-06
MODEL 5866-34A PACEMAKER LEAD ADAPTOR (K883203)Medtronic Vascular1988-09-06
BARD BAIM-TURI BALLOON DIAGNOSTIC PACING CATHETER (K882330)C.R. Bard, Inc.1988-09-06
RK2000 K-THERMIA SYSTEM (K882442)Baxter Healthcare Corp1988-09-06
HERAEUS WHITE (K883512)Degussa Dental, Inc.1988-09-06
BIOPORE VS.1 ENDOCARDIAL INTER IMPLANT PACING LEAD (K883602)Intermedics, Inc.1988-09-06
SURGICAL GOWN/SCRUB/LAPAROTOMY/MAYO STAND/BACK TAB (K883424)Intera Corp.1988-09-06
RASTIX X-RAY TABLE (K883155)Bay X-Ray, Inc.1988-09-06
DISPOSABLE ARACHNOID KNIFE (K882422)Microbio-Medics, Inc.1988-09-06
NUMED BALLOON THERMODILUTION CATHETER (K881893)NuMED, Inc.1988-09-06
UNDISTAT WITH EXPLORATOR 35 (UCS 35E) (K883153)Bay X-Ray, Inc.1988-09-06
PHOTO-CURING LIGHT (K882145)Dentsply Intl.1988-09-06
SAM(TM) MODEL ONE (K880725)Sentel Tech. C/O Criticare Systems, Inc.1988-09-06
BOW & ARROW DRILL GUIDE (K882407)Instrument Makar, Inc.1988-09-06
PATIENT VENTILATOR ISOLATOR (K880923)Dryden Corp.1988-09-06
ZEPHYR (K880534)Racal Health & Safety, Inc.1988-09-06
C/R GATING FOR ITS VISTA MR 2055/2055 UP & HP SYS (K883521)Philips Medical Systems (Cleveland), Inc.1988-09-02
L-F COILED EXTENSION TUBING (K882329)Mallinckrodt Group, Inc.1988-09-02
MULTI-CHEMISTRY LINEARITY STANDARD (K875285)Verichem Laboratories, Inc.1988-09-02
HERAEUS LASERSONICS ND:YAG LASER, MODEL 4900 (K882365)Heraeus Lasersonics, Inc.1988-09-02
RADKOR XG-325 (K881696)Radkor, Inc.1988-09-02
LX-80 AUTOMATED TISSUE PROCESSOR (PLASTIC) (K883599)Innovative Medical Systems, Inc.1988-09-02
RADKOR, XG-515 (K883081)Radkor, Inc.1988-09-02
STACHROM ANTIPLASMIN TEST KIT (K882602)American Bioproducts Co.1988-09-02
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TC (K881674)Shimadzu Precision Instruments, Inc.1988-09-02
LARYNGOSCOPE RIGID (K882433)Eastmed Enterprises, Inc.1988-09-02
PHADEBACT ETEC-LT TEST (K874288)Pharmacia, Inc.1988-09-02
STACHROM ANTIPLASMIN CONTROL (K882603)American Bioproducts Co.1988-09-02
AMBU TWIN PUMP - (MANUAL SUCTION PUMP) (K883433)Ambu, Inc.1988-09-02
RADKOR KOB-84 (K881700)Radkor, Inc.1988-09-02
GRID/RADIOGRAPHIC (K883527)Umi, Inc.1988-09-02
ABUSCREEN(R) ONTRAK(TM) FOR MORPHINE (K882496)Roche Diagnostic Systems, Inc.1988-09-02
RFA-300 RAPID FLOW ANALYZER W/COMPUTER (K883020)Alpkem Corp.1988-09-02
ARGYLE AUTOTRANSFUSION BAG (K882757)Sherwood Medical Co.1988-09-01
CX250 MOBILE GAMMA CAMERA & DCS CONSOLE (K880878)Philips Medical Systems (Cleveland), Inc.1988-09-01
EXPANDED CLAIMES TO OSTEOGEN(R) (K881662)Impladent1988-09-01
HEARING AID, UNITRON MODEL VISTA 1000 (K883513)Unitron Industries, Inc.1988-09-01
SYRINGE PUMP MS2000 (K880857)Smash Ent., Inc.1988-09-01
TRACER (K881842)Life-Tech Intl., Inc.1988-08-31
WHITESIDE ORTHOLOC II UNICONDYLAR KNEE SYSTEM (K881779)Dow Corning Wright1988-08-31
AD-HEAL(TM) WOUND DRESSING (K881731)Nepera, Inc.1988-08-31
OPER-FILM-ADHESIVE MEMBRANE (K881936)Iberhospitex, S.A.1988-08-31
DIGITAL BLOOD PRESSURE MONITOR MODEL HEM-703CP (K882393)Omron Electronics, Inc.1988-08-30
EBV-VCA IGM ANTIBODY TEST SYSTEM (ENZYME) (K880884)Immuno Concepts, Inc.1988-08-30
ANTI-RESPIRATORY SYNCYTIAL VIRUS ANTIBODY TEST (K882687)Gull Laboratories, Inc.1988-08-30
HARMAC EXTENSION INFUSION SET (K882347)Harmac Medical Specialties, Inc.1988-08-30
P.E.E.P. VALVE (K882219)Life Support Products, Inc.1988-08-30
DIGITAL MEDICINE ECG MONITOR AND RECORDER (K880971)Digital Medicine Systems1988-08-30
WAKO(TM) AUTOKIT AMYLASE (K883059)Wako Chemicals USA, Inc.1988-08-30
ALPHA-STIM 350 (K881753)Electromedical Products, Inc.1988-08-30
DC-LIQUICAL CATALOGUE #SE-030 (K882258)Diagnostic Chemicals, Ltd. (Usa)1988-08-30
HOUVA-BED (K882722)National Biological Corp.1988-08-30
EBV-VCA IGG ANTIBODY TEST SYSTEM (ENZYME) (K880885)Immuno Concepts, Inc.1988-08-30
ACS DEFLECTABLE TIP GUIDE WIRE W/MICROGLIDE(R)COAT (K882321)Advanced Cardiovascular Systems, Inc.1988-08-30
HEMOCHRON CONTROL PLASMA NORMAL/ABNORMAL LEV. I/II (K882480)International Technidyne Corp.1988-08-30
FLOSSIE (K883225)Richard G. Deniro1988-08-30
ALLEGRO ACTH IMMUNOASSAY KIT 65 AND 130 TUBES (K882741)Nichols Institute Diagnostics1988-08-30
28200 SERIES MICRO-ARTHRO. STERILE DISP. BLADES (K881715)KARL STORZ Endoscopy-America, Inc.1988-08-30
MODEL #716 ADULT STIM. PADS LOW IMPEDANCE GEL TYPE (K882338)Cardiotronics, Inc.1988-08-30
DART CARBON DIOXIDE (K883055)Coulter Electronics, Inc.1988-08-30
EBV-VCA IGG ANTIBODY TEST SYSTEM (FLUORESCENT) (K880883)Immuno Concepts, Inc.1988-08-30
HEMOCHRON CONTROL ACT TEST TUBE NORMAL/ABNOR. I/II (K882481)International Technidyne Corp.1988-08-30
DTR ANALYZER (K882913)Abbott Laboratories1988-08-30
METHENO-STAIN KIT (K883052)Scientific Device Laboratory, Inc.1988-08-30
MODEL P4/P4X BEHIND-THE-EAR HEARING AID W/PHOX (K882691)Maico Hearing Instruments, Inc.1988-08-30
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Every clearance here is in the API, with alerts when new ones post.