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
157225–157248 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 31, 1983
OR PREP KIT
K830476 · FRG
Clinipad Corp.
General Hospital · 44d
Cleared Mar 31, 1983
MODEL 50-01-27
K830490 · FRN
Windsor Medical, Inc.
General Hospital · 44d
Cleared Mar 31, 1983
SCOTTS TAP WATER SUBSTITUTE CONCENTRATE
K830515 · KEQ
Surgipath Medical Industries, Inc.
Pathology · 42d
Cleared Mar 31, 1983
STAINLESS STEEL SUTURE 316L
K830522
Sharpoint, Inc.
General & Plastic Surgery · 42d
Cleared Mar 31, 1983
WINDSOR MEDICAL, INC. 50-01-028
K830544 · FRN
Windsor Medical, Inc.
General Hospital · 37d
Cleared Mar 31, 1983
ERG-JET ELECTRODE
K830557 · HLZ
Universo S.A.
Gastroenterology & Urology · 36d
Cleared Mar 31, 1983
RENALIN (TENTATIVE
K830575 · LIF
Renal Systems, Inc.
Hematology · 36d
Cleared Mar 31, 1983
PUMP PALL AMBULATORY INSULIN INFUSION
K830605 · FRN
Biomedical Devices, Inc.
General Hospital · 34d
Cleared Mar 31, 1983
COMBION SKIN TEST
K830688 · LKH
Nicholas H. Maganias
Immunology · 27d
Cleared Mar 31, 1983
PRIME
K830691 · HIS
Ansell, Inc.
Obstetrics & Gynecology · 30d
Cleared Mar 31, 1983
VENES ANTI EMBOLISM STOCKINGS
K830696 · DWL
Futuro Div. Jung Corp.
General Hospital · 24d
Cleared Mar 31, 1983
WINGED CATHETER
K830765 · FOZ
Abbott Laboratories
General Hospital · 21d
Cleared Mar 31, 1983
WILLIAMS AIRWAY INTUBATOR
K830767 · CAE
Williams Airway Intubator
Anesthesiology · 20d
Cleared Mar 31, 1983
ENDO-GUARD
K830781 · FOG
Jayco Pharmaceuticals
Anesthesiology · 20d
Cleared Mar 29, 1983
MOUTH CARE KIT W/TOOTHBRUSH
K823413
Sage Products, Inc.
Dental · 134d
Cleared Mar 29, 1983
MECON I
K823788 · ESD
Mecon Labs
Ear, Nose, Throat · 103d
Cleared Mar 29, 1983
RMC TOTAL KNEE SYSTEM
K823837 · MBV
Richard'S Medical Equip., Inc.
Orthopedic · 98d
Cleared Mar 29, 1983
AMPCO KIDNEY DIALYSIS TRAY
K823839 · KOC
Associated Medical Products Co.
Gastroenterology & Urology · 98d
Cleared Mar 29, 1983
FREEMAN ACETABULAR CUP
K823843 · DXQ
Depuy, Inc.
Cardiovascular · 98d
Cleared Mar 29, 1983
IDAS INFUSION SET
K830194 · FPA
Idas America, Ltd.
General Hospital · 68d
Cleared Mar 29, 1983
FLORET DRAIN/TRACHEOTOMY SPONGE
K830265 · EFQ
Ritmed, Inc.
General & Plastic Surgery · 63d
Cleared Mar 29, 1983
SECURET DRAPE & INSTRUMENT RETAINER/INCL
K830276 · GTC
Ritmed, Inc.
Microbiology · 63d
Cleared Mar 29, 1983
FLORET GAUZE PACKING
K830278 · EFQ
Ritmed, Inc.
General & Plastic Surgery · 63d
Cleared Mar 29, 1983
WAK WEARABLE ARTIFICIAL KIDNEY
K830291 · KOC
Wak-Utah
Gastroenterology & Urology · 61d