Atlas FDA

1987

4,160 FDA 510(k) clearances · Clearance year

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RecordFirmDate
MODIFIED PROFILE HIP PMMA CEMENT SPACER (K871510)Depuy, Inc.1987-05-27
TRIPLE LUMEN INFUSION CATHETERIZATION SET OR KIT (K870412)Medical Surgical Concepts, Inc.1987-05-27
COMPOSITE RESTORATIVE CARRIER (K871909)Dentsply Intl.1987-05-27
ADVANCED MEDICAL SYSTEMS, KIT (K871322)The Jarid Group, Inc.1987-05-27
CANNULATED INSTRUMENT CLEANERS (K870765)Treace Medical, Inc.1987-05-27
TOP FORM II TRAYS, DISPOS FOAM-LINED TOP GEL APPLI (K871784)Colgate-Hoyt Laboratories1987-05-27
IV START KIT (K871281)The Jarid Group, Inc.1987-05-27
SCHULTZ PHALANGEAL COMP TRIAL/METACARPAL COMP TRIA (K870843)Warsaw Orthopedic, Inc.1987-05-27
CARERITE BIOPACK GINGIVAL RETRACTION CORD (K871736)Cost Rite Health Products, Inc.1987-05-27
CREATININE STANDARD SOLUTION CALIBRATOR (K871756)Wako Chemicals USA, Inc.1987-05-27
TECHNICON RA-XT(TM) SYSTEM IMMUNOASSAYS (K870998)Technicon Instruments Corp.1987-05-26
MCCONNELL ORTHOPEDIC TIBIAL POSITIONER (K871823)Mcconnell Orthopedic1987-05-26
ULTRAVIOLET ALANINE AMINO-TRANS (UV-ALT/UV-GPT) (K871782)Biochemical Trade, Inc.1987-05-26
NEFA STANDARD SOLUTION CALIBRATOR (K871763)Wako Chemicals USA, Inc.1987-05-26
BIOMEK 1000C AUTOMATED LABORATORY WORK STATION (K871838)Beckman Instruments, Inc.1987-05-26
MODEL 10-C WITH AN SA-10B/U OPTICAL ATTACHMENT (K870970)Directed Energy, Inc.1987-05-26
MCCONNELL ORTHOPEDIC ANTERIOR TORSO-ARM SUPPORT (K871820)Mcconnell Orthopedic1987-05-26
UREA N STANDARD SOLUTION CALIBRATOR (K871767)Wako Chemicals USA, Inc.1987-05-26
MODEL 20-C W/SA-20A/U OPTICAL ATTACHMENT/SURG USE (K870837)Directed Energy, Inc.1987-05-26
MAGNESIUM STANDARD SOLUTION CALIBRATOR (K871762)Wako Chemicals USA, Inc.1987-05-26
ASTRA(TM) SYSTEMS TRIGLYCERIDES CALIBRATOR 8 (K871150)Beckman Instruments, Inc.1987-05-26
NOILES TOTAL KNEE PROSTHESIS (K870730)Joint Medical Products Corp.1987-05-26
URIC ACID STANDARD SOLUTION CALIBRATOR (K871768)Wako Chemicals USA, Inc.1987-05-26
MODEL 20-C WITH AN SA-20B/U OPTICAL ATTACHMENT (K870971)Directed Energy, Inc.1987-05-26
MODEL 10-C W/ SA-10A/U OPTICAL ATTACHMENT/SURG USE (K870838)Directed Energy, Inc.1987-05-26
MCCONNELL ORTHOPEDIC U-HOOK ASSEMBLY (K871822)Mcconnell Orthopedic1987-05-26
CIBA CORNING MAGIC LITE ANALYZER II (K871874)Ciba Corning Diagnostics Corp.1987-05-26
KITS AND TRAYS FOR DIALYSIS USE (K871630)Dove Medical Supplies1987-05-26
GLUCOSE TESTCARD USE W/ILEX PROMPT CLINICAL CH ANA (K864282)Medical Device Consultants, Inc.1987-05-26
MCCONNELL ORTHOPEDIC POSTERIOR BODY SUPPORT (K871821)Mcconnell Orthopedic1987-05-26
MCCONNELL ORTHOPEDIC SUSPENSION SYSTEM (K871824)Mcconnell Orthopedic1987-05-26
MODEL U-1000 WITH GESTATIONAL AGE CALCULATION (K871385)Fukuda Denshi USA, Inc.1987-05-26
ARROW-CLARKE(TM) PLEURA-SEAL(TM) THORACENTESIS KIT (K870572)Arrow Intl., Inc.1987-05-26
MICROMEDIC NEONATAL T4 KIT (K871008)Micromedic Systems1987-05-26
KESTREL CONTACT LENS CASE (K871714)Applied Laboratories, Inc.1987-05-26
SYSTEM REAGENTS HITACHI 737 CALCIUM (EDTA) (K871811)Boehringer Mannheim Corp.1987-05-26
GLUCOSE STANDARD SOLUTION CALIBRATOR (K871758)Wako Chemicals USA, Inc.1987-05-26
COLORGENE DNA HYBRIDIZATION TEST FOR HSV CONFIRMA. (K870733)Enzo Biochem, Inc.1987-05-26
BED PATIENT PRESENCE MONITOR (K871203)Human Technologies, Inc.1987-05-26
TRIGLYCERIDE STANDARD SOLUTION CALIBRATOR (K871766)Wako Chemicals USA, Inc.1987-05-26
INORGANIC PHOSPHOROUS STANDARD SOLUTION CALIBRATOR (K871764)Wako Chemicals USA, Inc.1987-05-26
MCCONNELL ORTHOPEDIC PELVIC CALIPER SUPPORT (K871839)Mcconnell Orthopedic1987-05-26
SORBITOL MACCONKEY (SMAC) AGAR, DRI & PRE-FORM (K871855)Gibco Laboratories Life Technologies, Inc.1987-05-26
PHOSPHOLIPIDS STANDARD SOLUTION CALIBRATOR (K871765)Wako Chemicals USA, Inc.1987-05-26
MCCONNELL ORTHOPEDIC ANKLE POSITIONER (K871840)Mcconnell Orthopedic1987-05-26
SKIN GRAFT PRESERVATION MEDIUM (TISSUE) (K870451)Bioclinical Laboratory Services, Inc.1987-05-26
AUTOPAK NEONATAL TSH MONOCLONAL IRMA KIT (K871505)Micromedic Systems1987-05-26
CIBA CORNING MAGIC(R) LITE CKMB IMMUNOASSAY (K870987)Ciba Corning Diagnostics Corp.1987-05-26
MICROMEDIC NEONATAL TSH MONOCLONAL IRMA KIT (K870904)Micromedic Systems1987-05-26
SYVA Q-SPEC PHOTOMETER (K871307)Syva Co.1987-05-26
RF-1 CIRCUIT (K871592)Diagnostic Imaging Specialists Corp.1987-05-22
LUXTEC FIBEROPTIC CABLES (K864387)Luxtec Corp.1987-05-22
BABY E.T. TAPE(TM) (K871560)B&B Medical Technologies, Inc.1987-05-22
CSF-CARDIAC/PERITONEAL CATHETER (K871752)Pudenz-Schulte Medical Research Corp.1987-05-22
TDMAC-HEPARIN COATED RMI (K870421)Research Medical, Inc.1987-05-22
CIRCAMED FULL DISCLOSURE SYSTEM (K871251)Circadian, Inc.1987-05-22
APEX SUCTION CURETTE (K871384)Apex Medical, Inc.1987-05-22
ACS ENHANCED-TORQUE CORONARY GUIDING CATHETER (K871425)Advanced Cardiovascular Systems, Inc.1987-05-22
VIDEOSCAN (TM) (K871479)Kera Corp.1987-05-22
MODEL 10-C W/FL-10A/U OPTICAL ATTACHMENT/OPTHALMIC (K870839)Directed Energy, Inc.1987-05-22
IMPLANTABLE PACING LEAD MODELS 487-06 TO 430-01 (K871580)Intermedics, Inc.1987-05-22
KRONNER BI-PLANER TIBIA EXTERNAL FIXATION (K871249)Kronner Medical1987-05-22
MCCONNELL ORTHOPEDIC SHOULDER/HIP POSITIONER (K871819)Mcconnell Orthopedic1987-05-22
KRONNER UNIVERSAL FRAME EXTERNAL FIXATION (K871247)Kronner Medical1987-05-22
CUI TISSUE EXPANDER VERSAFIL(TM) TISSUE EXPANDER (K865056)Cox-Uphuff Intl.1987-05-22
OLYMPIC SMART SCALE (K871104)Olympic Medical Corp.1987-05-22
GESCO ASPIRATOR (K870962)Gesco Intl., Inc.1987-05-22
RADIOPAQUE SPHERICAL EMBOLI (RSE) (K871047)Interventional Therapeutics Corp.1987-05-22
QM2/QM300 CONTROL A PACK (K871342)Kallestad Diag, A Div. of Erbamont, Inc.1987-05-21
CARHILL ONE-WAY RESUSCITATION VALVE (K864681)Life Design Systems, Inc.1987-05-21
SARNS 9000 HEART-LUNG CONSOLE (K871131)3M Health Care, Sarns1987-05-21
C150-P ECG CABLES (K870926)Desco Industries, Inc.1987-05-21
GBNA MEDIUM (K871786)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-05-21
IMPLANTABLE ELECTRODE LEAD, MODEL 030-439 (K864618)Telectronics, Inc.1987-05-21
BIOSURGE MODEL OASYS (K871258)Biosurge, Inc.1987-05-21
ENDOTRACHEAL TUBE HOLDER (K864526)Mathew Medical Co.1987-05-21
MODEL 366-12 ADAPTAID (TM) STEP-DOWN ADAPTER (K871625)Intermedics, Inc.1987-05-21
ELECTRODE, PACEMAKER, PERMANENT & TEMPORARY (K870357)Intermedics, Inc.1987-05-21
STACHROM PROTEIN C TEST KIT (K871039)American Bioproducts Co.1987-05-21
QM300 CALIBRATOR A PACK (K871341)Kallestad Diag, A Div. of Erbamont, Inc.1987-05-21
SILVER STAIN REAGENT SYSTEM (K871476)Sigma Chemical Co.1987-05-21
TRI-LEVEL LIGAND CONTROL (K864877)Ciba Corning Diagnostics Corp.1987-05-21
ALLOY FOR DENTAL AMALGAM LUXALLOY NON GAMMA 2 (K870230)Degussa Dental, Inc.1987-05-20
SYNTRON BIORESEARCH EZ CHECK HCG PREGNANCY TEST (K870751)Syntron Bioresearch, Inc.1987-05-20
URINOSCOPY FUNNEL (K871671)Portable Medical Laboratories, Inc.1987-05-20
FAST-PATCH(TM) (K871224)Physio-Control Corp.1987-05-20
TYPE 316L COTTER WIRE (K864375)Winn Hirsch & Assoc.1987-05-20
TYTEM(R) REAGENT DISPENSER (K871687)Medical Laboratory Automation Systems, Inc.1987-05-20
MRS AGAR AND MRS BROTH (K871702)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-05-20
BLOXOM IRRIGATOR (K871791)I.B. Bloxom C/O Hogan & Hartson1987-05-20
PROPHYLACTIC (CONDOM) MR. JOHNNY (K865106)Medelec Intl. Corp.1987-05-20
ABBOTT TESTPACK HCG COMBO (K870739)Abbott Laboratories1987-05-20
FOLLICLE STIMULATING HORMONE (HFSH) (K871317)Immuchem Corp.1987-05-20
S-CAL HEMATOLOGY CALIBRATOR (K862122)Coulter Electronics, Inc.1987-05-20
ARYLSULFATASE BROTH (K871701)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-05-20
IONOCAL (K871562)Foremost Dental Mfg., Inc.1987-05-20
MCCONNELL ORTHOPEDIC STERILE ARTICULATED ARM (K871703)Mcconnell Orthopedic1987-05-19
TELSTAR MODEL 0/3 HEARING AID (K871519)Telstar Electronics, Inc.1987-05-19
MCCONNELL ORTHOPEDIC UNIVERSAL POSITIONER (MUP) (K871803)Mcconnell Orthopedic1987-05-19
DMI AMBULATORY HOLTER MONITOR (K871045)Diagnostic Medical Instruments1987-05-19
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Every clearance here is in the API, with alerts when new ones post.