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
125161–125184 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jul 20, 1990
SURG-K SURGICAL KERATOMETER
K901553 · HLR
The Sanborn Co.
Ophthalmic · 108d
Cleared Jul 20, 1990
1 TRANSDUCER FOR COMBISON 310A
K901655 · ITX
Kretztechnik AG
Radiology · 102d
Cleared Jul 20, 1990
INTRA III AND INTRA IV HEARING AIDS
K901860 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 87d
Cleared Jul 20, 1990
COATEST LMW HEPARIN/HEPARIN CHROMOGENIC ASSAY
K901874 · KFF
Kabi Diagnostica
Hematology · 85d
Cleared Jul 20, 1990
I3SYSTEM-ABD
K902007 · IYO
Innovative Imaging, Inc.
Radiology · 77d
Cleared Jul 20, 1990
SEAL RITE(TM)
K902022 · EBC
Pulpdent Corp.
Dental · 77d
Cleared Jul 19, 1990
EXEL HUBER INFUSION SET
K895770 · FPA
Exel Intl.
General Hospital · 296d
Cleared Jul 19, 1990
METRICARE ENTERAL FEEDING SYSTEM
K895923 · FPD
Metrix Co.
Gastroenterology & Urology · 281d
Cleared Jul 19, 1990
DECIDENT
K896364 · EKY
Nevin Laboratories, Inc.
Dental · 255d
Cleared Jul 19, 1990
GENESYS 6000 GAMMA COUNTER
K900087 · JJJ
Laboratory Technologies, Inc.
Toxicology · 195d
Cleared Jul 19, 1990
IONOMETER EH-F AND ACCESSORIES
K901040 · JGS
Fresenius USA, Inc.
Chemistry · 135d
Cleared Jul 19, 1990
ISOFLO(TM) HIGH PRESSURE INJECTION LINES
K901382 · DXT
Healthdyne Cardiovascular, Inc.
Cardiovascular · 119d
Cleared Jul 19, 1990
BIURET (COLORMETRIC), TOTAL PROTEIN
K901527 · CEK
American Research Products Co.
Chemistry · 108d
Cleared Jul 19, 1990
LIGHT, HEAD, EXAMINATION
K901706 · KZF
Burton Medical Products Corp.
General Hospital · 98d