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
175153–175176 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 20, 1976
GRAFT, COOLEY WOVEN VASCULAR, STERILE
K760092 · DSY
Meadox Medicals, Div. Boston...
Cardiovascular · 29d
Cleared Jul 20, 1976
RESPIRIZOR
K760095 · CAF
Campillary Systems
Anesthesiology · 29d
Cleared Jul 20, 1976
PROSTHESIS, TOTAL HIP-FEMORAL
K760106 · JDG
Orthopedic Equipment Co., Inc.
Orthopedic · 26d
Cleared Jul 20, 1976
PROSTHESIS, TOTAL HIP-TEST FEMORAL
K760107 · JDG
Orthopedic Equipment Co., Inc.
Orthopedic · 26d
Cleared Jul 20, 1976
PROSTHESIS, TOTAL HIP-TEST CUP
K760108 · JDG
Orthopedic Equipment Co., Inc.
Orthopedic · 26d
Cleared Jul 20, 1976
PROSTHESIS, TOTAL HIP-RASP
K760109 · HTR
Orthopedic Equipment Co., Inc.
General & Plastic Surgery · 26d
Cleared Jul 20, 1976
THERMOMETER, DIGITAL FEVER (MEDITEMP)
K760118 · FLL
Johnson & Johnson Professionals, Inc.
General Hospital · 25d
Cleared Jul 20, 1976
SAMPLER, FLAMELESS (IL MODEL 555)
K760119 · JXR
Instrumentation Laboratory CO
Chemistry · 25d
Cleared Jul 20, 1976
PULSE CARDULE (MODEL 1859/1860 ECG)
K760120 · DRT
Spacelabs, Inc.
Cardiovascular · 22d
Cleared Jul 20, 1976
AUTOZYME
K760123 · KSK
Bd Becton Dickinson Vacutainer...
Hematology · 22d
Cleared Jul 20, 1976
AUTO CELL DILUENT
K760124 · GIF
Bd Becton Dickinson Vacutainer...
Hematology · 22d
Cleared Jul 20, 1976
LENS, HARD CONTACT
K760126 · HPX
Tru-Form Optics, Inc.
Ophthalmic · 22d
Cleared Jul 20, 1976
SALINE, ISOTONIC BUFFERED, AZIDE-FREE
K760129 · GIF
Harleco
Hematology · 22d
Cleared Jul 20, 1976
PROSTHESIS, VASCULAR BIFURCATED
K760130 · DSY
Usci, Div. C.R. Bard, Inc.
Cardiovascular · 22d
Cleared Jul 20, 1976
AGARO-GEL, PRODUCT # A1266
K760131 · JJN
Sigma Chemical Co.
Chemistry · 22d
Cleared Jul 20, 1976
TEST, RIA, TSH QUANTIMUNE
K760132 · JLW
Bio-Rad
Immunology · 22d
Cleared Jul 20, 1976
PROCEDURE, RED CELL FOLATE ASSAY
K760133 · CGN
Bio-Rad
Chemistry · 22d
Cleared Jul 20, 1976
PROCEDURE, RA, THYROXINE BINDING PROTEIN
K760134 · CEE
Bio-Rad
Chemistry · 22d
Cleared Jul 20, 1976
TEST, RA, QUANTA-COUNT T-4
K760135 · CDX
Bio-Rad
Immunology · 22d
Cleared Jul 20, 1976
CATHETER, THORACIC DRAIN
K760136 · DWS
Sherwood Medical Industries
Cardiovascular · 22d
Cleared Jul 20, 1976
SERUM, ALPHA-1-GLYCOPROTEIN ANTI-HUMAN
K760143 · DEX
Oxford Laboratories, Inc.
Immunology · 21d
Cleared Jul 20, 1976
SERUM, HAPTOGLOBIN GOAT ANTI-HUMAN ACID
K760144 · DAD
Oxford Laboratories, Inc.
Immunology · 21d
Cleared Jul 20, 1976
SERUM, IGA GOAT ANTI-HUMAN ACID
K760146 · CZP
Oxford Laboratories, Inc.
Immunology · 21d
Cleared Jul 20, 1976
SERUM, IGM ANTI-HUMAN ACID
K760147 · DFT
Oxford Laboratories, Inc.
Immunology · 21d