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
92833–92856 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 08, 1997
QUALITROL UNASSAYED H. PYLORI CONTROL SET POSITIVE AND NEGATIVE CONTROLS
K972146 · LYR
Consolidated Technologies, Inc.
Microbiology · 29d
Cleared Jul 08, 1997
TBD
K972273 · GEI
Megadyne Medical Products, Inc.
General & Plastic Surgery · 20d
Cleared Jul 07, 1997
CAPIOX 308 HOLLOW FIBER OXYGENATOR W/INTEGRATED HEAT EXCHANGE
K961734 · DTZ
Terumo Medical Corp.
Cardiovascular · 430d
Cleared Jul 07, 1997
EPILIGHT HAIR REMOVAL SYSTEM
K963249 · GEX
Esc Medical Systems , Ltd.
General & Plastic Surgery · 322d
Cleared Jul 07, 1997
MANUAL RESUSCITATOR
K963848 · BTM
Owens-Brigam Medical Co.
Anesthesiology · 285d
Cleared Jul 07, 1997
OCULAR CONFORMER
K970318 · HQN
Southwest Artificial Eyes, Inc.
Ophthalmic · 160d
Cleared Jul 07, 1997
OCULAR CONFORMER
K970319 · HQN
Xavier A. Guerra, Ocularist, Inc.
Ophthalmic · 160d
Cleared Jul 07, 1997
SCLERAL SHELL
K970320 · HQT
Xavier A. Guerra, Ocularist, Inc.
Ophthalmic · 160d
Cleared Jul 07, 1997
SCLERAL SHELL
K970327 · HQT
Southwest Artificial Eyes, Inc.
Ophthalmic · 160d
Cleared Jul 07, 1997
CMS CRYOLITE
K970995 · GEH
Cryomedical Sciences, Inc.
General & Plastic Surgery · 110d
Cleared Jul 07, 1997
PRECINORM TDM CONTROLS
K971060 · DIF
Boehringer Mannheim Corp.
Chemistry · 105d
Cleared Jul 07, 1997
ULTRACISION 5MM LAPAROSONIC HOOK BLADES, ULTRACISION HS2 BLADE
K971302 · LFL
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 90d
Cleared Jul 07, 1997
BIOSIGN STREP A - DIRECT STREP A ANTIGEN TEST
K971349 · GTY
Princeton BioMeditech Corp.
Microbiology · 88d
Cleared Jul 07, 1997
IVALON INSTRUMENT WIPE, IVALON KNIFE CLEANING BLOCK
K971473 · GEC
M-Pact Worldwide Management Corp.
General & Plastic Surgery · 75d
Cleared Jul 07, 1997
DOYLE COMBO NASAL AIRWAY SPLINT
K972151 · LYA
Boston Medical Products, Inc.
Ear, Nose, Throat · 28d
Cleared Jul 07, 1997
DADE TRU-LIQUID BILIRUBIN CONTROL
K972287 · JJX
Dade Intl., Inc.
Chemistry · 18d
Cleared Jul 03, 1997
NOVIGUARD QUICK DRY
K961044 · LRJ
Dr. Novis Smith & Co., Inc.
General Hospital · 476d
Cleared Jul 03, 1997
2008H ON LINE CLEARANCE MONITOR
K961465 · KDI
Fresenius USA, Inc.
Gastroenterology & Urology · 442d
Cleared Jul 03, 1997
MS401097-17,MS722-K,MS720,MS721,MS722
K962767 · HLJ
Alexander Mfg. Co.
Ophthalmic · 352d
Cleared Jul 03, 1997
MEDTRONIC MODEL 3991A, 3992A, 3993A, 3994A LEADS OR TRANSVERSE TRIPOLAR LEADS...
K964172 · GZB
Medtronic Vascular
Neurology · 258d
Cleared Jul 03, 1997
SILKAIR LOW AIRLOSS THERAPY
K964873 · IOQ
Hill-Rom, Inc.
Physical Medicine · 210d
Cleared Jul 03, 1997
N-ASSAY TIA MULTI CRP CALIBRATOR SET
K965110 · DCK
Crestat Diagnostics, Inc.
Immunology · 195d
Cleared Jul 03, 1997
INSIGHT DIAGNOSTIC IMAGING WORKSTATION NIT-DU0-ZOO
K965179 · LLZ
Neo Imagery Technologies, Inc.
Radiology · 191d
Cleared Jul 03, 1997
ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP
K965230 · FRN
Abbott Mfg., Inc.
General Hospital · 184d