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
125017–125040 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 10, 1990
AEROMIST II NEBULIZER
K901315 · CAF
Inhalation Plastics
Anesthesiology · 173d
Cleared Sep 10, 1990
MODIFICATION TO API UNISCEPT 20GP
K901559 · LQL
Analytical Products, Inc.
Microbiology · 160d
Cleared Sep 10, 1990
RAD-X GLASSES
K902280 · HQY
Compudrug
Ophthalmic · 111d
Cleared Sep 10, 1990
CYTOSET(TM)
K902589 · HHT
Birchwood Laboratories, Inc.
Obstetrics & Gynecology · 90d
Cleared Sep 10, 1990
CYTETTE(TM) CYTOLOGY BRUSH
K902591 · HHT
Birchwood Laboratories, Inc.
Obstetrics & Gynecology · 90d
Cleared Sep 10, 1990
DIRECTIGEN FLU A
K902609 · GNT
Bd Becton Dickinson Vacutainer...
Microbiology · 90d
Cleared Sep 10, 1990
MICROSCOPE DRAPE
K902851 · HMW
Medical Technique Instruments, Inc.
General Hospital · 73d
Cleared Sep 10, 1990
CIBA CORNING ACS DIGOXIN IMMUNOASSAY
K902861 · DON
Ciba Corning Diagnostics Corp.
Chemistry · 74d
Cleared Sep 10, 1990
SURGICAL LIGHTING-CENTRA 450
K902864 · FSY
Sds Dental, Inc.
General & Plastic Surgery · 73d
Cleared Sep 10, 1990
BAUMER SURGICAL TABLE
K902865 · BWN
Sds Dental, Inc.
General & Plastic Surgery · 73d
Cleared Sep 10, 1990
CUSTOMED ARTHROSCOPY PACK
K902887 · LRO
Customed, Inc.
General & Plastic Surgery · 70d
Cleared Sep 10, 1990
CUSTOMED ORTHOPEDIC II
K902888 · LRO
Customed, Inc.
General & Plastic Surgery · 70d
Cleared Sep 10, 1990
CELL-DYN CALIBRATOR
K902892 · KRZ
Unipath , Ltd.
Hematology · 70d
Cleared Sep 10, 1990
GYREX 2T VERSION 2.1U.
K903028 · LNH
Elscint, Inc.
Radiology · 61d
Cleared Sep 10, 1990
ABBOTT VISION LYTE (TM) SODIUM
K903188 · JGS
Abbott Laboratories
Chemistry · 53d
Cleared Sep 10, 1990
CUI ARTICULATED SILICONE CHIN
K903327 · FWP
Cui Corp.
General & Plastic Surgery · 47d
Cleared Sep 10, 1990
CUI PREMAXILLARY IMPLANT
K903328 · FZE
Cui Corp.
General & Plastic Surgery · 47d
Cleared Sep 10, 1990
CUI ANATOMICAL SILICONE MALAR
K903329 · LZK
Cui Corp.
General & Plastic Surgery · 47d
Cleared Sep 10, 1990
TDX FREE T4 CALCULATION
K903383 · CEC
Abbott Laboratories
Chemistry · 45d
Cleared Sep 10, 1990
IMX FREE T4 CALCULATION
K903384 · CEC
Abbott Laboratories
Chemistry · 45d
Cleared Sep 10, 1990
MICKEY/MINNIE MOUSE BATT. OPERATE TOOTHBRUSH
K903510 · JEQ
Helm Toy Corp.
Dental · 38d
Cleared Sep 10, 1990
DSL ANDROSTANEDIOL GLUCURONIDE (DSL #6000)
K903616 · JKC
Diagnostic Systems Laboratories, Inc.
Chemistry · 33d
Cleared Sep 10, 1990
STERNOTOMY CABLE, SONGER CABLE SYSTEM
K903676 · JDQ
Danek Medical, Inc.
Orthopedic · 28d
Cleared Sep 10, 1990
COMPANION 318 NASAL CPAP SYSTEM
K903764 · BYE
Puritan Bennett Corp.
Anesthesiology · 21d