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
125737–125760 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 24, 1990
ABNORMAL GLYCOHEMOGLOBIN CONTROL
K902457 · LCP
Analytical Control Systems, Inc.
Hematology · 50d
Cleared Jul 24, 1990
WEEVAC 1 PORTABLE RESCUE STRETCHER
K902474 · FPP
W. Murphy Ent., Inc.
General Hospital · 49d
Cleared Jul 24, 1990
LANDERS VITRECTOMY LENS RING W/INFUSION
K902496 · HNH
Ocular Instruments, Inc.
Ophthalmic · 49d
Cleared Jul 24, 1990
SAXON RIBBED CONDOMS
K902509 · HIS
Safetex Corp.
Obstetrics & Gynecology · 49d
Cleared Jul 24, 1990
MITEK ANCHOR II
K902751 · JDR
Mitek Surgical Products, Inc.
Orthopedic · 32d
Cleared Jul 24, 1990
TOXOPLASMA GONDII IGG
K902792 · LGD
Pharmacia Diagnostics, Inc.
Microbiology · 28d
Cleared Jul 24, 1990
THERMOSCAN-INSTANT THERMOMETER MODEL IR-4000
K902912 · FLL
Thermoscan, Inc.
General Hospital · 21d
Cleared Jul 23, 1990
KRONNER SPHERICAL CUTTERS
K894228 · HWT
Kronner Medical
Orthopedic · 399d
Cleared Jul 23, 1990
PHARMATRONICS NEBULIZER
K896536 · CAF
Diversatronics, Inc.
Anesthesiology · 250d
Cleared Jul 23, 1990
SPIRO ANALYZER MODEL ST 250
K901308 · BZG
Futuremed Div. of Future Impex Corp.
Anesthesiology · 125d
Cleared Jul 23, 1990
INSTRUMENTS FOR NEUROLOGICAL SURGERY
K901313 · HAE
Von Zeppelin GmbH
Neurology · 125d
Cleared Jul 23, 1990
ANATOMIC MODULAR KNEE (AMK) POSTERIOR STABILIZED
K901406 · JWH
Depuy, Inc.
Orthopedic · 119d
Cleared Jul 23, 1990
WALLACE INTRAUTERINE INSEMINATION CATHETER
K901530 · EJT
Gynescope Corp.
Dental · 112d
Cleared Jul 23, 1990
TEGADERM BRAND TRANSPARENT DRESSING SERIES 16XX
K901845 · KGX
3M Company
General & Plastic Surgery · 90d
Cleared Jul 23, 1990
E.T. TAPE II
K902065 · CBH
B&B Medical Technologies, Inc.
Anesthesiology · 76d
Cleared Jul 23, 1990
OPTILASE MODEL 1000 ND:YAG LASER ADD'L INDICATION
K902263 · GGX
Trimedyne, Inc.
Hematology · 63d
Cleared Jul 23, 1990
PRECISION MEDICAL NEB BLOCK
K902916 · BXY
Precision Medical, Inc.
Anesthesiology · 20d
Cleared Jul 23, 1990
PRECISION MEDICAL ELIMINATOR
K902917 · BXY
Precision Medical, Inc.
Anesthesiology · 20d
Cleared Jul 20, 1990
FOLEY CATHETER INSERTION TRAY (30CC)
K901180 · FCM
Orion Life Systems, Inc.
Gastroenterology & Urology · 129d
Cleared Jul 20, 1990
CATHETER CARE TRAY
K901181 · FCM
Orion Life Systems, Inc.
Gastroenterology & Urology · 129d
Cleared Jul 20, 1990
URETHRAL CATHETER TRAY (PVC)
K901183 · FCM
Orion Life Systems, Inc.
Gastroenterology & Urology · 129d
Cleared Jul 20, 1990
URETHRAL CATHETER TRAY (LATEX)
K901184 · FCM
Orion Life Systems, Inc.
Gastroenterology & Urology · 129d
Cleared Jul 20, 1990
FOLEY CATHETER INSERTION TRAY (10CC)
K901185 · FCM
Orion Life Systems, Inc.
Gastroenterology & Urology · 129d
Cleared Jul 20, 1990
L SOPHIA
K901512 · LHD
Nishitomo Co., Inc.
Obstetrics & Gynecology · 113d