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
169153–169176 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 05, 1979
TEE ADAPTER
K790887 · BZA
Airlife, Inc.
Anesthesiology · 29d
Cleared Jun 05, 1979
TWO-WAY ANESTHESIA FILTER
K790896 · CAH
Pharmaseal Div., Baxter Healthcare Corp.
General Hospital · 28d
Cleared Jun 05, 1979
GORDON IVS INTRAVENOUS STABILIZER
K790946 · GBJ
Whitman Medical Corp.
General & Plastic Surgery · 18d
Cleared Jun 05, 1979
CLAMP COVERS
K790952 · GAD
Medi-Spec
General & Plastic Surgery · 14d
Cleared Jun 05, 1979
KIMLON IMPERVIOUS STOCKINETTES
K790972 · KKX
Kimberly-Clark Corp.
General Hospital · 14d
Cleared Jun 05, 1979
REYNOLDS DOUBLE HEMOCLIP APPLIERS
K790990 · GDO
Edward Weck, Inc.
General & Plastic Surgery · 6d
Cleared Jun 04, 1979
LEADS, IMPLANTABLE CARDIAC PACEMAKERS
K782018 · DTB
Oscor, Inc.
Cardiovascular · 181d
Cleared Jun 01, 1979
CAP, TAMPER PROOF PLASTIC
K782113 · KPE
Acacia, Inc.
General Hospital · 164d
Cleared Jun 01, 1979
AUTO TRAUMA KIT
K790411 · KME
Marshall Electronics, Inc.
General Hospital · 95d
Cleared Jun 01, 1979
QUICKSCAN HOLTER II
K790476 · DSH
Intl. Medical, Inc.
Cardiovascular · 88d
Cleared Jun 01, 1979
BROWNE MODEL UD-4DE
K790478 · FAP
Browne Corp.
Gastroenterology & Urology · 84d
Cleared Jun 01, 1979
ENDOCARDIAL PACING LEAD, MODEL 476-01
K790548 · DTB
Intermedics, Inc.
Cardiovascular · 73d
Cleared Jun 01, 1979
ALARM
K790559 · FRN
Maddak, Inc.
General Hospital · 74d
Cleared Jun 01, 1979
VITALITH S 3000 SERIES
K790666 · DXY
Vitatron Medical BV
Cardiovascular · 56d
Cleared Jun 01, 1979
TECNOL BODY HOLDER
K790699 · FMQ
Tecnol New Jersey Wound Care, Inc.
General Hospital · 50d
Cleared Jun 01, 1979
TOUCHLESS TM FOLEY CATHETER KIT
K790728 · KOD
Diamed Division Ill. Tool Works, Inc.
Gastroenterology & Urology · 49d
Cleared Jun 01, 1979
BROWNE MODEL CF-1 AND CF-1G
K790754 · FAP
Browne Corp.
Gastroenterology & Urology · 45d
Cleared Jun 01, 1979
LIFEPAK 5 MONITOR, CASSETTE, #800923-01
K790757 · DSH
Physio-Control Corp.
Cardiovascular · 45d
Cleared Jun 01, 1979
FETASONDE MODEL 2108
K790761 · HGM
Roche Medical Electronics, Inc.
Obstetrics & Gynecology · 45d
Cleared Jun 01, 1979
ULTIPOR SOLUTION CONTAINER FILTER
K790879 · FPB
Pall Biomedical Products Co.
General Hospital · 25d
Cleared Jun 01, 1979
MODEL 113 TREONIC IP3 DIGITAL SYRINGE PU
K790945 · FRN
Vickers America Medical Corp.
General Hospital · 14d
Cleared Jun 01, 1979
ECG ELECTRODES, PEDIATRIC-FOAM TAPE
K791002 · DRX
Physio-Control Corp.
Cardiovascular · 3d
Cleared Jun 01, 1979
ECG ELECTRODES, PEDIATRIC-MICROPOROUS TA
K791003 · DRX
Physio-Control Corp.
Cardiovascular · 3d
Cleared May 31, 1979
HLA-2000
K790513 · DRM
Bdt Ent.
Cardiovascular · 77d