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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
113353–113376 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 26, 1993
H-110 ACETABULAR CUP SYSTEM
K926323 · JDI
Implex Corp.
Orthopedic · 161d
Cleared May 26, 1993
VISTA(R) HUMAN LUTEINIZING HORMONE(HLH) ASSAY
K926394 · CEP
Syva Co.
Chemistry · 156d
Cleared May 26, 1993
ROCHE COBAS(R)-FP REAGENT FOR TOTAL T4 THYROX/CALI
K926441 · KLT
Roche Diagnostic Systems, Inc.
Chemistry · 154d
Cleared May 26, 1993
ANAGO WARM PACK
K926589 · IMD
Anago, Inc.
Physical Medicine · 170d
Cleared May 26, 1993
ANAGO DISPOSABLE INSTANT COLD PACK
K926590 · IMD
Anago, Inc.
Physical Medicine · 170d
Cleared May 26, 1993
URESIL VALVE CUTTER WITH INTERCHANGEABLE HEADS
K930011 · MGZ
Uresil Corp.
Cardiovascular · 142d
Cleared May 26, 1993
RTM REHABILITATION TREADMILL, MODEL #945-200
K930261 · IOL
Biodan Medical Systems, Ltd.
Physical Medicine · 127d
Cleared May 26, 1993
COBAS CORE LH EIA
K930306 · CEP
Roche Diagnostic Systems, Inc.
Chemistry · 125d
Cleared May 26, 1993
CATHETER GUIDEWIRE (PERIPHERAL USE)
K930961 · DQX
Target Therapeutics
Cardiovascular · 91d
Cleared May 26, 1993
BIOTROL AMYLASE CNPG3
K931141 · CIJ
Biotrol, USA, Inc.
Chemistry · 82d
Cleared May 26, 1993
CHECKMATE PLUS BLOOD GLUCOSE METER, TEST STRIP,ETC
K931188 · CGA
Cascade Medical, Inc.
Chemistry · 78d
Cleared May 26, 1993
KODAK EKTACHEM TOTAL IRON-BINDING CAPACITY KIT
K931493 · JMO
Eastman Kodak Company
Chemistry · 62d
Cleared May 25, 1993
IMAGE-X 70 INTRAORAL X-RAY SYSTEM
K930761 · EAP
Afp Imaging Corp.
Radiology · 102d
Cleared May 25, 1993
VGA-50 GOLD ALLOY
K931089 · EJT
Vident
Dental · 83d
Cleared May 25, 1993
PALLADIUS-6 ALLOY SEMI-PRECIOUS ALLOY
K931090 · EJT
Vident
Dental · 83d
Cleared May 24, 1993
SELECTIVE INFUSION II CATHETER
K914751 · KRA
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 580d
Cleared May 24, 1993
HOSPITAL KIT DK 117
K922130 · MDM
Savoy Medical Supply Co., Inc.
General & Plastic Surgery · 383d
Cleared May 24, 1993
DETECTO MODEL 6700 SERIES
K924847 · FRW
Cardinal Scale Mfg. Co.
General Hospital · 238d
Cleared May 24, 1993
M.I.S. TROCAR-CANNULA
K925276 · GCS
M.I.S. Technology, Inc.
Gastroenterology & Urology · 216d
Cleared May 22, 1993
EXPANSION SCREWS
K925088 · DYJ
Forestadent
Dental · 227d
Cleared May 21, 1993
MEDIX PC-305 NEONATAL INCUBATOR
K920049 · FMZ
Medix I.C.S.A.
General Hospital · 501d
Cleared May 21, 1993
SHARPE ENDOSPONGE ASPIIRATOR
K921015 · HET
Paladin Medical, Inc.
Obstetrics & Gynecology · 444d
Cleared May 21, 1993
ULTRA THIN MENSTRUAL PAD
K921115 · HHD
Icd Products
Obstetrics & Gynecology · 438d
Cleared May 21, 1993
LUNEAU UMBILICAL CORD CLAMP
K923439 · HFW
Laboratoires Luneau
Obstetrics & Gynecology · 312d