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
144697–144720 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 14, 1986
MODEL NY-110 FOR UPPER & LOWER (GU) & PULMONARY
K860496 · LNK
Xanar, Inc.
Gastroenterology & Urology · 32d
Cleared Mar 14, 1986
SERUM LIPASE REAGENT SET (TURBIDIMETRIC)
K860554 · CFG
Sterling Diagnostics, Inc.
Chemistry · 28d
Cleared Mar 14, 1986
ANDROSTENEDIONE 125I KIT BY RIA
K860559 · CIZ
Immuchem Corp.
Chemistry · 28d
Cleared Mar 14, 1986
SYNATOMIC REVISION FEMORAL PROSTHESIS
K860594 · JWH
Depuy, Inc.
Orthopedic · 23d
Cleared Mar 14, 1986
INORGANIC PHOSPHORUS REAGENT SET
K860628 · CEO
Sterling Diagnostics, Inc.
Chemistry · 23d
Cleared Mar 14, 1986
OPTI-FIX TOTAL HIP SYSTEM
K860635 · LPH
Richards Medical Co., Inc.
Orthopedic · 22d
Cleared Mar 14, 1986
M.C.R. KNEE PROSTHESIS (SERIES 3000)
K860654 · JWH
Osteonics Corp.
Orthopedic · 21d
Cleared Mar 14, 1986
AMRESCO FLOW PAC CARBON DIOXIDE (CO2) REAGENTS
K860660 · CHS
Amresco, Inc.
Chemistry · 18d
Cleared Mar 14, 1986
AMRESCO FLOW PAC ALBUMIN BROMOCRESOL GREEN REAGENT
K860661 · CIX
Amresco, Inc.
Chemistry · 18d
Cleared Mar 14, 1986
AMRESCO FLOW PAC CHLORIDE REAGENT NO. 2256 & 2271
K860662 · CHJ
Amresco, Inc.
Chemistry · 18d
Cleared Mar 14, 1986
ERIKA ARTERIAL LINE 03-9625-9
K860740 · FJK
National Medical Care, Medical...
Gastroenterology & Urology · 15d
Cleared Mar 14, 1986
MCBRIDE LISTERIA AGAR
K860861 · JSJ
Gibco Laboratories Life Technologies,...
Microbiology · 7d
Cleared Mar 13, 1986
WELCH ALLYN MODEL 40000 SPHYG W/ 40030-35 BLAD & C
K852574 · DXN
Welch Allyn, Inc.
Cardiovascular · 268d
Cleared Mar 13, 1986
SCANO 731B & 731C ULTRASOUND SOFT TIS DEPT MEAS SY
K853147 · IYO
Scano, Inc.
Radiology · 227d
Cleared Mar 13, 1986
TRAVENOL DISPOSABLE DENTAL SCALERS/CURETTES
K854168 · ELA
Travenol Laboratories, S.A.
Dental · 149d
Cleared Mar 13, 1986
PE-3000 PULSE RATE MONITOR
K854198 · DRT
Quantum Life Systems, Inc.
Cardiovascular · 149d
Cleared Mar 13, 1986
ENDOMETRIAL PIPELLE
K854415 · HHK
Unimar, Inc.
Obstetrics & Gynecology · 129d
Cleared Mar 13, 1986
RENAMEL ESTHETIC RESTORATIVE SYSTEM
K854755 · EBF
Cosmedent, Inc.
Dental · 106d
Cleared Mar 13, 1986
FILTERED VACUUM SAFETY TRAP BOTTLE
K855074 · KDQ
Boehringer Laboratories
General Hospital · 84d
Cleared Mar 13, 1986
THACKRAY TOTAL CONDYLAR KNEES
K855166 · JWH
Thackray USA
Orthopedic · 77d
Cleared Mar 13, 1986
PANAVIA EX, A DENTAL ADHESIVE
K855211 · EMA
Kuraray Co.
Dental · 73d
Cleared Mar 13, 1986
HOSPITAL TABBED NAPKINS SUPER BELTED FEMININE NAPK
K860294 · HHD
I.C.D. Industries, Inc.
Obstetrics & Gynecology · 44d
Cleared Mar 13, 1986
THE POREX RETRACTOR TABLE
K860503 · FSE
Porex Medical
General & Plastic Surgery · 30d
Cleared Mar 13, 1986
KOTEX OVERNITE
K860587 · HHD
Kimberly-Clark Corp.
Obstetrics & Gynecology · 22d