FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
168865–168888 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 30, 1979
QUANTIMUNE T-4 FIA
K790576 · CDX
Bio-Rad
Chemistry · 124d
Cleared Jul 30, 1979
RIA, DIGNXIN-125-I
K790602 · DPB
Endocrine-Metabolic Center
Chemistry · 125d
Cleared Jul 30, 1979
STERAID SURGICAL DRESSING
K790631 · EFQ
Corda Intl. Holdings, Inc.
General & Plastic Surgery · 118d
Cleared Jul 30, 1979
HYPERBARIC OXYGEN CHAMBER
K790693 · CBF
Hyperbaric Oxygen Therapy, Inc.
Anesthesiology · 111d
Cleared Jul 30, 1979
IIF-APCA TEST KIT
K790759 · DBJ
Medica Corp.
Immunology · 104d
Cleared Jul 30, 1979
EXETER BONE LAUAGE SYSTEM
K790811 · FQH
Howmedica Corp.
General Hospital · 95d
Cleared Jul 30, 1979
GUARDIAN II I.V. CONTROLLER
K790836 · FLN
Centaur Sciences, Inc.
General Hospital · 91d
Cleared Jul 30, 1979
VAGI-PRESS #401
K790851 · KOH
C. Intl.
Obstetrics & Gynecology · 87d
Cleared Jul 30, 1979
VAGI-SPEC
K790852 · KNA
C. Intl.
Obstetrics & Gynecology · 87d
Cleared Jul 30, 1979
EASY-SPEC
K790853 · KNA
C. Intl.
Obstetrics & Gynecology · 87d
Cleared Jul 30, 1979
MONOJECT ENDOMETRIAL SAMPLING KIT
K790875 · HHK
Sherwood Medical Co.
Obstetrics & Gynecology · 84d
Cleared Jul 30, 1979
PREG-TEX
K790898 · JHJ
Biologics Intl., Inc.
Chemistry · 82d
Cleared Jul 30, 1979
DISPOSABLE ADULT DIAPER
K790922 · EYQ
Fibre Formations, Inc.
Gastroenterology & Urology · 76d
Cleared Jul 30, 1979
SOMATOM 2
K790975 · JAK
Siemens Corp.
Radiology · 68d
Cleared Jul 30, 1979
3M CEMENT REMOVER
K791056 · HSZ
3M Company
Orthopedic · 52d
Cleared Jul 30, 1979
IMMUNOSPOT TSH TEST
K791065 · JLW
Meloy Laboratories, Inc.
Chemistry · 48d
Cleared Jul 30, 1979
AUTOMATED ELECTROPHORESES MACHINE
K791111 · JJN
Gelman Sciences, Inc.
Chemistry · 46d
Cleared Jul 30, 1979
MACOMB NORMAL CONTROL SERUM
K791119 · JJY
Macomb Chemical Co.
Chemistry · 45d
Cleared Jul 30, 1979
POSIVAC
K791127 · CBN
Vital Signs, Inc.
Anesthesiology · 42d
Cleared Jul 30, 1979
COLO-TAPE
K791146 · EZR
Suburban Ostomy Supply Co., Inc.
Gastroenterology & Urology · 42d
Cleared Jul 30, 1979
ECG CHANNEL OF DIAGNOSTIC SYSTEM
K791151 · DPS
Honeywell, Inc.
Cardiovascular · 40d
Cleared Jul 30, 1979
AMIPAQUE MYELOGRAM TRAY
K791156 · FMI
Pharmaseal Div., Baxter Healthcare Corp.
General Hospital · 39d
Cleared Jul 30, 1979
DINAMAP MODEL 855
K791159 · DXN
Applied Medical Research
Cardiovascular · 39d
Cleared Jul 30, 1979
DEXIDE DISPOSABLE PREP STICK
K791168 · KXF
Dexide, Inc.
General Hospital · 35d