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
125833–125856 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 24, 1990
KLEIN LAMPREY-CANNULA(TM)
K901718 · GEA
Jeff Klein Surgical, Inc.
General & Plastic Surgery · 41d
Cleared May 24, 1990
M.D.C. PORTA-LIFT
K901793 · ING
Metal Dynamics Corp.
Physical Medicine · 35d
Cleared May 24, 1990
CHICK III SURGICAL LIGHTING SYSTEM
K901830 · FSY
Chick Medical Products
General & Plastic Surgery · 30d
Cleared May 24, 1990
GRAVITY DOWN WHEELCHAIR LIFT
K901989 · ING
Crow River Industries, Inc.
Physical Medicine · 22d
Cleared May 23, 1990
ACUSON L538 TRANSDUCER
K893863 · ITX
Acuson Computed Sonography
Radiology · 364d
Cleared May 23, 1990
FLEXMEDICS GUIDEWIRE .012 ONLY
K895899 · DQX
Flexmedics
Cardiovascular · 229d
Cleared May 23, 1990
WIDEX BTE HEARING AID MODEL Q16 WITH REMOTE
K897033 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 156d
Cleared May 23, 1990
MIRACLE EAR MODEL PC PROG. IN-THE-EAR HEARING AID
K897035 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 156d
Cleared May 23, 1990
PHONAK ITE 8000, 7000, 6000 ITE HEARING AID
K900675 · ESD
Phonak, Inc.
Ear, Nose, Throat · 100d
Cleared May 23, 1990
PANORAMIC MODEL X-CALIBER X-RAY
K900681 · EAP
Belmont Equipment Corp.
Radiology · 100d
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