FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
126433–126456 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 23, 1990
NUCLEAR MAX
K900773 · IYX
Scientific Imaging, Inc.
Radiology · 96d
Cleared May 23, 1990
BTE SUPER-FRONT PPSCL, SUPER-FRONT PPSC
K900829 · ESD
Phonak, Inc.
Ear, Nose, Throat · 91d
Cleared May 23, 1990
BTE SUPER-FRONT PPCL4, SUPER-FRONT PPC4
K900830 · ESD
Phonak, Inc.
Ear, Nose, Throat · 91d
Cleared May 23, 1990
BTE PICO SCD, PICO SC
K900831 · ESD
Phonak, Inc.
Ear, Nose, Throat · 91d
Cleared May 23, 1990
TRANSVAGINAL TRANSDUCER ASSEMBLY
K900838 · HGL
Pie Medical Equipment B.V.
Obstetrics & Gynecology · 90d
Cleared May 23, 1990
MODEL 366 HEARING AID
K900846 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 90d
Cleared May 23, 1990
URIC ACID TEST KIT
K901001 · KNK
Elite Technology, Inc.
Chemistry · 82d
Cleared May 23, 1990
REP HEMOGLOBIN IEF KITS (CAT. NO. 3250)
K901143 · JBD
Helena Laboratories
Hematology · 72d
Cleared May 23, 1990
COULTER CK (CREATINE KINASE) REAGENT
K901267 · CGS
Coulter Corp.
Chemistry · 68d
Cleared May 23, 1990
WIDEX HEARING AID MODEL THE DISCOVERY
K901642 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 44d
Cleared May 23, 1990
ROCHE REAGENT FOR MAGNESIUM
K901758 · JGJ
Roche Diagnostic Systems, Inc.
Chemistry · 35d
Cleared May 23, 1990
ADD'L SOFTWARE VERSION D2 FOR MAGNETOM 42 AND 63
K901818 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 30d
Cleared May 22, 1990
FUJINON EDU SYSTEM
K894763 · ITX
Fujinon, Inc.
Radiology · 299d
Cleared May 22, 1990
ANGIO-MAX
K900034 · DXT
Accumed Systems, Inc.
Cardiovascular · 140d
Cleared May 22, 1990
FLUOR-I-CHAINS(TM) AND FLUOR-I-TIES(TM)
K900824 · EJF
Midwest Orthodontic Mfg.
Dental · 90d
Cleared May 22, 1990
NON STERILE PARENTERAL SUPPLY KIT
K900857 · FMF
Intermed, Inc.
General Hospital · 88d
Cleared May 22, 1990
COBE AIR EMBOLI PROTECTION SYSTEM (AEPS)
K900910 · DTW
Cobe Laboratories, Inc.
Cardiovascular · 84d
Cleared May 22, 1990
O'DONNELL, SOCKET RECONSTRUCTION PROSTHESES
K901002 · HQX
Oculo Plastik, Inc.
Ophthalmic · 81d
Cleared May 22, 1990
FLEXIBLE CHOLEDOCHOSCOPE
K901010 · FBN
Intramed Laboratories, Inc.
Gastroenterology & Urology · 78d
Cleared May 22, 1990
SUB-CLAVIAN CATHETERS SLSC 1300, 1500 AND 2000
K901061 · LFJ
Akcess Medical Products, Inc.
Gastroenterology & Urology · 78d
Cleared May 22, 1990
MEDISONIC HUMDIFIER/INHALER
K901114 · CAF
Medisonic U.S.A., Inc.
Anesthesiology · 76d
Cleared May 22, 1990
KOAGULAB 60-S COAGULATION SYSTEM
K901120 · GKP
Ortho Diagnostic Systems, Inc.
Hematology · 71d
Cleared May 22, 1990
SARA SATCAP
K901132 · CCK
Ppg Industries, Inc.
Anesthesiology · 71d
Cleared May 22, 1990
MODEL 9101 RECORDER/ANALYZER SYSTEM
K901251 · DSH
Aequitron Medical, Inc.
Cardiovascular · 67d