Atlas FDA

1988

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

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RecordFirmDate
SCEPTOR STAPHYLOCOCCUS MIC/ID PANEL #80325 (K883551)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-09-27
SCEPTOR PSEUDOMONAS PLUS MIC/ID PANEL #80329 (K883554)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-09-26
SCEPTOR STREPTOCOCCUS MIC/ID PANEL #80323 (K883548)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-09-26
SCEPTOR RESISTANT GRAM-NEGATIVE MIC/ID #80332 (K883555)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-09-26
FLOWTRON DVT SYSTEM AC500 PUMP, L501 GARMENT (K881632)Huntleigh Technology, Inc.1988-09-26
SIMPSON PERIPHERAL ATHEROCATH W/ADDIT. SIZE 13F (K883346)Devices For Vascular Intervention, Inc.1988-09-26
MYOTRAC (K881416)Thought Technology , Ltd.1988-09-26
PTI HEART-LIFT(TM) CARDIAC ELEVATOR (STERILE) (K883135)Pioneering Technologies, Inc.1988-09-26
SCIMED ULTROX TRUE MEMBRANE OXY. ULTROX I & II (K883054)Scimed Life Systems, Inc.1988-09-26
VIR-A-VAC EMPTY (K882315)Viratec Corp.1988-09-26
VERIPOID 50 BIO-ELECTRICAL IMPEDANCE METER (K881851)Micro Medical, Ltd.1988-09-26
BASIC HEATER-COOLER UNIT, 115/100V 16-02-20 (K883330)Shiley, Inc.1988-09-26
SLT CONTACT LASER SYSTEM ENDOPHOTOCOAGULATION (K882441)Surgical Laser Technologies, Inc.1988-09-26
VASCULAR ACCESS PORT/CATHETER NO.VP-XXX VASPORT (K882969)Gish Biomedical, Inc.1988-09-26
BASIC HEATER-COOLER UNIT W/MAST, 115/110V 16-21-10 (K883331)Shiley, Inc.1988-09-26
FEF(TM) END-TIDAL CO2 DETECTOR (K883821)Fenem, Inc.1988-09-26
SCEPTOR STREPTOCOCCUS MIC PANEL #80322 (K883549)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-09-26
MAST FOR BASIC HEATER-COOLER UNIT 16-09-00 (K883332)Shiley, Inc.1988-09-26
SCIMED MEMBRANE OXYGENATOR, MODEL 0600-2A (K883053)Scimed Life Systems, Inc.1988-09-26
SCEPTOR STAPHYLOCOCCUS MIC #80324 (K883550)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-09-26
VITAL-VUE ILLUMINATION, SUCTION & IRRIGATION SYS (K883201)Vital Metrics, Inc.1988-09-26
629V SPIROMETER, PULMONARY FUNCTION ANALYZER (K881402)American Electromedics Corp.1988-09-26
SCEPTOR PSEUDOMONAS PLUS MIC PANEL CAT.# 80328 (K883552)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-09-26
WCCS 800 WALLACH CARDIAC CRYOSURGICAL SYSTEM (K880416)Wallach Surgical Devices, Inc.1988-09-26
SCEPTOR RESISTANT GRAM-NEGATIVE MIC PANEL #80331 (K883553)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-09-26
DUAL-TEMP(TM) COOLING/WARMING UNIT (K882310)Seabrook Medical Systems, Inc.1988-09-23
CASF DRILL GUIDE DG 170 (K882871)Terray Manufacturing, Inc.1988-09-23
COLTENE PRESIDENT JET REGULAR BODY (K882800)Coltene, Inc.1988-09-23
SAFESITE INJECTION SITE AND BLUNT CANNULA (K883638)Baxter Healthcare Corp1988-09-23
AREA (DENTAL CHAIR) (K880474)Alpine Dental Equipment Co.1988-09-23
CARDIAC PACE. OPUS 4000 MODELS 4043/4044/4063/4066 (K882427)Ela Medical, Inc.1988-09-23
STERILE EMPTY GLASS VIALS (K883686)Farris Laboratories, Inc.1988-09-23
SKEMA (DENTAL UNIT) (K880475)Alpine Dental Equipment Co.1988-09-23
IVY COMMANDER, MODEL 600 (K882167)Ivy Medical, Inc.1988-09-23
FLOWTRON AC200/2 (K874688)Huntleigh Technology, Inc.1988-09-23
GARDS DEODORANT SANITARY NAPKIN (K882094)Hospital Specialty Co.1988-09-22
AMERLITE TSH ASSAY, LAN.0001/2001 240 & 144 KIT (K882907)Amersham Corp.1988-09-22
PARKER BATHING SYSTEM (K883308)Mid-Canada Medical1988-09-22
QM300 CONTROL F PACK (K883712)Kallestad Diag, A Div. of Erbamont, Inc.1988-09-22
HIP FRACTURE STEM SYSTEM (K883179)Howmedica Corp.1988-09-22
TECHNICON DPA-1 IMMUNOGLOBULIN M (K883493)Technicon Instruments Corp.1988-09-22
EPICARDIA PC/FC (K883103)Medicomp, Inc.1988-09-22
EMPI MODEL 727,NMS (K882631)Empi1988-09-22
TECHNICON DPA-1 IMMUNOGLOBULIN A (K883492)Technicon Instruments Corp.1988-09-22
HERAEUS DG 63 (K883509)Degussa Dental, Inc.1988-09-22
HERA H (K883508)Degussa Dental, Inc.1988-09-22
QM300 CALIBRATOR D PACK (K883001)Kallestad Diag, A Div. of Erbamont, Inc.1988-09-22
MODIFIED AMANA ELECTROTHERAPEUTIC SYSTEM (K875072)Amana Medical Group1988-09-22
NOVA LITE(TM) SA (K881341)Inova Diagnostics, Inc.1988-09-22
QUIDEL PREGNANCY TEST CONTROL (K883316)Quidel Corp.1988-09-22
AXIAL COMPRESSION SCREW (K883715)Straub Clinic and Hospital1988-09-22
ACCESS R-CLONE(TM) ANA/RF SCREENING ASSAY (K882740)Lipogen, Inc.1988-09-22
SL SERIES, SL 15, 18, 20 & 25 (MODIFICATION) (K882231)Philips Medical Systems, Inc.1988-09-22
SPINAL MICROKNIFE (K882525)Karlin Technology, Inc.1988-09-22
QM300 CALIBRATOR F PACK (K883711)Kallestad Diag, A Div. of Erbamont, Inc.1988-09-22
DU PONT DIMENSION C-REACTIVE PROTEIN METHOD (K883515)E.I. Dupont DE Nemours & Co., Inc.1988-09-22
TECHMEDICA MP SYSTEM (K882922)Techmedica, Inc.1988-09-22
AVL MODEL 986 ELECTROLYTE ANALYZER (K883240)Avl Scientific Corp.1988-09-22
VISTA MR 2055 HP SYSTEM (K883378)Philips Medical Systems (Cleveland), Inc.1988-09-22
EVENT MARKER & A SECOND PRESSURE TREND OUTPUT (K883518)Metatech Corp.1988-09-22
SPECIFIC ALLERGEN MODULES FOR ALASTAT(TM) (K883616)Diagnostic Products Corp.1988-09-22
QM300 PREALBUMIN ANTIBODY PACK (K883002)Kallestad Diag, A Div. of Erbamont, Inc.1988-09-22
COMPEED ATHLETIC DRESSING (K883588)Coloplast A/S1988-09-22
ITE HEARING AID, SIEMENS MODEL 007, WITH TELOS (K882678)Siemens Hearing Instruments, Inc.1988-09-22
MEDACORD PVL, PERSONAL VASCULAR LABORATORY (K882018)Medasonics, Inc.1988-09-21
CORPAK PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE (K882867)Corpak Co.1988-09-21
KING KONDOM (CONDOM) (K882009)King Kondom Products, Inc.1988-09-21
THE OMNI-FLOW THERAPIST INFUSION MANAGEMENT SYSTEM (K882594)Omni-Flow, Inc.1988-09-20
QUIK-PACE II ELECTRODES (K883121)Physio-Control Corp.1988-09-20
PHYSIOTRON(TM) MICROSURGICAL MOTOR & COOLING SYS. (K882654)Surgical Innovators of America, Inc.1988-09-20
HOLTER SCANNER (K881488)Cardiodata Corp.1988-09-20
Q-CATH RM (K883031)Quinton, Inc.1988-09-20
TRANSERVICAL ENDOSCOPE (HYSTEROSCOPE) (K882761)Intramed Laboratories, Inc.1988-09-20
JOBST EXTREMITY PUMP(R) SYSTEM 7500 (K882683)Jobst Institute, Inc.1988-09-20
HEART HUGGER STERNUM SUPPORT HARNESS (K882592)General Cardiac Technology, Inc.1988-09-20
SYNCHRON CX4/CX5 CLINICAL CHEMISTRY ANALYZER REAGE (K883181)Beckman Instruments, Inc.1988-09-19
ELECTROSTIMULATOR MODEL 808 (K880426)Cornell Enterprises Co., Inc.1988-09-19
MODIFIED LASERFLO BLOOD PERFUSION MONITOR, BPM403A (K875179)Tsi, Inc.1988-09-19
MODEL #1553 RECLINER INTERFACE (K880362)Invacare Corp.1988-09-19
MODEL #1551 SWITCH CONTROL INTERFACE UNIT (K880360)Invacare Corp.1988-09-19
MODEL #1554 PNEUMATIC SWITCH (K880363)Invacare Corp.1988-09-19
EXCELVIEW ILLUMINATOR (K883702)Excel Medical Products, Inc.1988-09-19
BARBITURATE ENZYME IMMUNOASSAY KIT (K882663)General Diagnostics1988-09-19
PXI (PERSONAL X-RAY IMAGER) 512 (K881993)Oklahoma Digital Technologies, Inc.1988-09-19
VARIAN CLINAC 1800S (K882326)Varian Assoc., Inc.1988-09-19
MEVATRON, M 2 CLASS (K882729)Siemens Medical Laboratories, Inc.1988-09-19
COULTER VISCOMETER II (K883503)Coulter Electronics, Inc.1988-09-19
A.C.I. TRACH TIE (K882891)Auxiliary Care, Inc.1988-09-19
EMIT (R) HVA NEGATIVE URINE (K883210)Syva Co.1988-09-19
HOSPITAL BED CLOTHING CRADLE (K883463)Commercial Products & Engineering Co.1988-09-19
MAMMO M (K882133)Ziehm International, Inc.1988-09-19
MODEL #1556 HEAVY-DUTY JOYSTICK (K880365)Invacare Corp.1988-09-19
MODEL #1552 ATTENDANT CONTROL OPTION (K880361)Invacare Corp.1988-09-19
ALKPHOR(TM) SYSTEM, HUMAN SERUM ALKA PHOS ISOENZY (K883395)Quantimetrix Medical Industries1988-09-19
MODEL #1555 REMOTE JOYSTICK (K880364)Invacare Corp.1988-09-19
PROCEDURE PACKS PRESS. MONITOR/ADMINISTRATION LINE (K882655)Procedure Packs, Inc.1988-09-16
MRL OXIMETER (K882664)Medical Research Laboratories, Inc.1988-09-16
POLYSAFE IMPLANT. PACING LEADS W/TINED FIXA. TIP (K883016)Cardiac Control Systems, Inc.1988-09-16
CHANG MEDIUM (ADDITIONAL INDICATIONS) (K883682)Hana Biologics, Inc.1988-09-16
ET HI-FLOW SOFT TIP/ET HI-FLOW/ENHANCED TORQUE ST (K882803)Advanced Cardiovascular Systems, Inc.1988-09-16
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Every clearance here is in the API, with alerts when new ones post.