Atlas FDA

1

32,815 FDA 510(k) clearances · Device class

Sort:Newest firstOldest first

Download CSV table Client report (share link) ◉ Watch

Both buttons carry the same predicate table: the CSV downloads for your worksheet, the report is a shareable page for clients. Exports: 3 free/month with an account · reports & watching free.

RecordFirmDate
SODIUM/POTASSIUM SERUM RANGE LINEARITY STANDARDS (K881436)Hichem Diagnostics1988-06-02
FACTOR II PROSTHETIC SILICONE ELASTOMER (K880329)Factor, Ii, Inc.1988-06-01
MINILINE BRACKET (K881789)Alexotek Co.1988-06-01
SYNCHRON CX(TM)4 CLINICAL ANALYZER (K881498)Beckman Instruments, Inc.1988-06-01
STERILE SURGICAL LATEX GLOVE (K881821)Nca Med Intl./Noble House, Inc.1988-06-01
PERMA-PIC PLASTIC TOOTHPICK (K881900)The Perma-Pic Co.1988-06-01
ACUFEX SUTURE RETRIEVER, STERILE DISPOSABLE (K881224)Acufex Microsurgical, Inc.1988-06-01
SYNCHRON CX(TM)5 CLINICAL ANALYZER (K881495)Beckman Instruments, Inc.1988-06-01
STERILE SURGEONS GLOVES (K881756)Packaging Technologies, Inc.1988-06-01
SAFESKIN STERILE SURGEONS GLOVES (K880446)Safeskin Corp.1988-06-01
RIA-QUICK (K881194)Quantitative Technologies, Inc.1988-06-01
AUDINA (K882004)American Audio Services, Inc.1988-06-01
DAHLBERG MODEL XJ 8080 BODY-WORN HEARING AID (K881612)Dahlberg Electronics, Inc.1988-06-01
REP LIPO KIT CAT. NO 3180 (K881809)Helena Laboratories1988-06-01
INCOS 50 MASS SPECTROMETER (K880418)Finnigan Corp.1988-05-31
CARDICAD(TM) (K881392)Medical/Surgical Specialties, Ltd.1988-05-31
URI-CHEM(R) GK,2,3,4C,5CN,6C,7C AND 8C (K880584)Mach Diag. C/O Wichita State University1988-05-31
UVMAX KINETIC MICROPLATE READER (K881803)Molecular Devices Corp.1988-05-31
PAR(TM) BRAND DRUG OF ABUSE CONTROLS (K880152)Medical Analysis Systems, Inc.1988-05-31
GAMMA GLUTAMYL TRANSFERASE REAGENT SET (K881239)Tech-Neal Scientific, Inc.1988-05-31
ABBOTT BREATH ACETONE ANALYZER (K875029)Abbott Laboratories1988-05-27
SPECTRUM(TM) BLOOD GAS AND ELECTROLYTE CONTROL (K881655)Biomedical Research & Development Laboratories, Inc.1988-05-27
GAMMA-GLUTAMYL TRANSFERASE (K881626)Tech-Co, Inc.1988-05-27
BIOTROL TRIGLYCERIDES ENZYMATIQUE UV H.P. (K881702)Biotrol, USA, Inc.1988-05-27
AUTO TROL(TM) CONTROL, LEVELS 1 & 2 #16692 & 16693 (K881229)Em Diagnostic Systems, Inc.1988-05-27
RAICHEM(TM) MAGNESIUM REAGENT, ENZYMATIC (K880880)Reagents Applications, Inc.1988-05-27
LIQUID CHROMATO. COLUMNS (K880724)Supelco, Inc.1988-05-27
LIPASE UV [TOYO] (K874027)Advocacy International, Ltd.1988-05-27
HDL CHOLESTEROL PRECIPITATING PROCEDURE (K881326)Data Medical Associates, Inc.1988-05-27
FSH ENZYME IMMUNOASSAY TEST KIT NO. MB-1057 (K881596)Medix Biotech, Inc.1988-05-27
MULTI-FUNCTION BLOOD GAS CONTROL (K880447)Bionostics, Inc.1988-05-27
HIP SAVER (K882090)Pride Health Care, Inc.1988-05-26
CYTOJARS PREFILLED WITH CYTOLOGY PRESERVATIVE (K881922)Surgipath Medical Industries, Inc.1988-05-25
PLASTIC FRAME & LENS SUNGLASS (K881419)Marketing Innovations Intl., Inc.1988-05-25
ATS NAC-PAC SET (K881949)Alpha-Tec Systems, Inc.1988-05-25
SPECTACLE, FRAME AND SUNGLASSES (K881278)Nouvelle Ligne Paris1988-05-25
SUNGLASSES (K881594)Transfers Intl., Inc.1988-05-25
LIFESTYLE SOF. CARE GEL CHAIR CUSHION (K882012)Gaymar Industries, Inc.1988-05-23
CHLAMYDIAZYME(TM) (K880469)Abbott Laboratories1988-05-23
TEAR VOLUME TESTS (K881515)Visionex, Inc.1988-05-23
EBNA ANTIBODY (K875170)Hillcrest Biologicals1988-05-23
C-STAT/1000 (K880876)Sonne Medical, Inc.1988-05-20
GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER (K880871)John Wagner Associates, Inc.1988-05-20
EMERGENCY-CLEAN UP(TM) ECP (K880306)Cdc Products Corp.1988-05-20
RIDE-LITE 9000 SERIES WHEELCHAIR (K881951)Invacare Corp.1988-05-19
MODIFIED IDS RAPID NH SYSTEM (K881501)Innovative Diagnostic Systems, Inc.1988-05-18
IMPULSE TVC (RICHARDS, OMNI, MARCON) (K881143)Richards Medical Co., Inc.1988-05-18
EDWARDS-DUROMEDICS BILEAFLET VALVE SIZER SET (K881279)Baxter Healthcare Corp1988-05-18
ACCUTONE IN-THE-EAR HEARING AID (K881193)Interstate Hearing Aid Service1988-05-18
OCO PREPARATIONS (K874396)Williams Importing Company, Inc.1988-05-18
INTRODUCTION/DRAINAGE CATHETER & ACCESS (K881873)Sheridan Catheter Corp.1988-05-18
BREATH-EASY (K881308)Icor AB1988-05-17
MAGNESIUM LIQUID STABLE REAGENT SET (K881300)Medical Analysis Systems, Inc.1988-05-17
URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & II (K881275)Fisher Scientific Co., LLC1988-05-16
CONDOM-MATE VAGINAL LUBRICANT (K881338)Upsher-Smith Laboratories, Inc.1988-05-16
TRICHOMATE(R) SUPER (K875138)Mercia Diagnostics , Ltd.1988-05-13
BREAST LOCALIZATION NEEDLES (K881730)Hart Enterprises, Inc.1988-05-13
ITE TYPE HEARING AID ABS MODEL (K880938)A Better Sound Corp.1988-05-13
SNAP(R) ROTAVIRUS DIAGNOSTIC KIT (K873565)Molecular Biosystems, Inc.1988-05-13
AUDIOTONE MODEL AVATAR IN-THE-EAR HEARING AID (K881737)Audiotone, Inc.1988-05-13
WESCOR MODEL 7300 AEROSPRAY GRAM STAINER (K881592)Wescor, Inc.1988-05-13
ATS CRYPTOSPORIDIUM STAIN SET (K880989)Alpha-Tec Systems, Inc.1988-05-13
ATS PVA FIXATIVE SOLUTION (K881698)Alpha-Tec Systems, Inc.1988-05-13
MVR/STILETTO BLADE 20GA. - P/N 1900 (K881669)Advanced Surgical Products, Inc.1988-05-13
AUDIOTONE MODEL TLC SECRET IN-THE-EAR HEARING AID (K881738)Audiotone, Inc.1988-05-13
AUDIOTONE MODEL ASP SECRET IN-THE-EAR HEARING AID (K881653)Audiotone, Inc.1988-05-13
SUPER PIK MASSAGING PICK FOR ORAL HYGIENE (K881046)U.S. Dentek Corp.1988-05-13
ORTHO MONOLERT* RAPID ELISA TEST FOR INFECT. MONO. (K872541)Ortho Diagnostic Systems, Inc.1988-05-13
ATS M/15 PHOSPHATE BUFFER, PRODUCT #034-42 (K881879)Alpha-Tec Systems, Inc.1988-05-13
DRI-CLAVE LIQUID KLEENZALL (K880754)Columbus Dental Mfg. Co.1988-05-12
AMALGAMATOR (K880993)Acecodent, Inc.1988-05-11
DATALOGGER CHART RECORDER (K880781)Air-Shields, Inc.1988-05-11
ROTA-DENT TOOTH CLEANER (K880589)Pro-Dentec1988-05-11
EXAMIX DISPENSER (K880849)G-C Intl. Corp.1988-05-11
AUDIOTONE MODEL A-61 BEHIND-THE-EAR HEARING AID (K881652)Audiotone, Inc.1988-05-11
NATELSON TUBES, HEPARIN AND PLAIN (K881187)Helps Products, Inc.1988-05-06
CARAWAY TUBES, HEPARIN AND PLAIN (K881262)Helps Products, Inc.1988-05-06
CATHRA GRAM POSITIVE SCREEN (K874606)Mct Medical, Inc.1988-05-06
ABBOTT TESTPACK RSV (K874127)Abbott Laboratories1988-05-06
ULTRA-PAN FOR ORTHOTIC PLASTICS (7262) (K880644)Fred Sammons, Inc.1988-05-06
RESUBMITTED ABBOTT TESTPACK ROTAVIRUS (K880821)Abbott Laboratories1988-05-06
VSM(R) R2 PAPER CHART RECORDER (K880554)Physio-Control Corp.1988-05-06
THREE PHASE, DIAGNOSTIC X-RAY GENERATOR MICRO-X 80 (K880522)Fischer Imaging Corp.1988-05-04
SINGLE PHASE DIAG. X-RAY GENERATOR MICRO-X 650 (K880519)Fischer Imaging Corp.1988-05-04
THREE PHASE, DIAGNOSTIC GENERATOR MICRO-X 75 (K880523)Fischer Imaging Corp.1988-05-04
SINGLE PHASE DIAGNOSTIC X-RAY GENERATOR FX-650 (K880521)Fischer Imaging Corp.1988-05-04
THREE PHASE DIAGNOSTIC X-RAY GENERATOR MICRO-X 100 (K880524)Fischer Imaging Corp.1988-05-04
SDL TRICHROME STAIN (K881598)Scientific Device Laboratory, Inc.1988-05-04
ARTUS DISPOSABLE SHEATHS/CUTTERS (K880881)Acufex Microsurgical, Inc.1988-05-04
ROLLS 2000 SERIES WHEELCHAIR (K881762)Invacare Corp.1988-05-04
HR-5000 ELECTROSURGICAL DEVICE FOR NEW INDICATIONS (K881276)Ime Co. , Ltd.1988-05-04
CANNULAS (K880346)Myocure, Inc.1988-05-03
ANESTHESIA/RETROBULBAR NEEDLES (K880347)Myocure, Inc.1988-05-03
CYSTOTOMES/KNIFES (K880345)Myocure, Inc.1988-05-03
BLUE PLASTIC EYE SHIELD (K880490)Eye Garter Company, Inc.1988-05-03
AUTOMATIC PERIMETER, AP-340 (K881219)Kowa Optimed, Inc.1988-05-03
OCU-1 (K875030)Rudolph Beaver, Inc.1988-05-03
SUREDROP EYEDROP GUIDE (K874569)Suredrop, Inc.1988-05-03
DENTALVISION TV SYSTEM (K880542)Dentsply Intl.1988-05-02
RESUBMITTED ERGOMETER EXERCISE BIKE MODEL FT1300 (K880865)Invacare Corp.1988-05-02
← Previous Next →

Track 1 automatically

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