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
109969–109992 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 16, 1994
I/V POLE
K935226 · KYG
Optical Micro Systems, Inc.
Ophthalmic · 107d
Cleared Feb 16, 1994
SPECTACLE FRAMES
K935605 · HQZ
Sovereign Eyewear, Inc.
Ophthalmic · 89d
Cleared Feb 16, 1994
SUNGLASS FRAME
K935678 · HQY
Australian Optical Co., Inc.
Ophthalmic · 82d
Cleared Feb 16, 1994
OPTICAL FRAMES AND/OR SUNGLASSES
K935729 · HQZ
Ivo Eyewear, Inc.
Ophthalmic · 77d
Cleared Feb 16, 1994
MULTIPLE -SPECTACLE FRAMES/SUNGLASSES
K935798 · HQZ
Tae Kyung Optical Co., Inc.
Ophthalmic · 76d
Cleared Feb 16, 1994
SPECTACLE FRAME
K935918 · HQZ
Kenmark Optical Co., Inc.
Ophthalmic · 69d
Cleared Feb 16, 1994
SUNGLASSES
K935919 · HQG
Ja-Ru, Inc.
Ophthalmic · 70d
Cleared Feb 16, 1994
OPTICAL FRAME COLLECTION NO. 2
K935954 · HQZ
Frontier Novelty, Inc.
Ophthalmic · 65d
Cleared Feb 16, 1994
AURIUM 224
K940111 · EJT
Argen Precious Metals, Inc.
Dental · 37d
Cleared Feb 15, 1994
FLOWMATE HAND PUMP
K915459 · KOD
Psi Medical Products, Inc.
Gastroenterology & Urology · 804d
Cleared Feb 15, 1994
ULA (POLIGLECAPRONE 251) SYNTHETIC ABSOR SUT, DYED
K920978 · GAN
Ethicon, Inc.
General & Plastic Surgery · 715d
Cleared Feb 15, 1994
METALLIC TOATAL HIP SYSTEM
K921274 · LPH
Biomet, Inc.
Orthopedic · 700d
Cleared Feb 15, 1994
WILTEK IRRIGAITON/ASPIRATION TUBE SET
K922989 · BYY
Wiltek Medical, Inc.
General Hospital · 603d
Cleared Feb 15, 1994
EXPLORER, OPERATIVE
K925888 · EKJ
Protector, Inc.
Dental · 456d
Cleared Feb 15, 1994
FORCEPS, DRESSING, DENTAL
K925889 · EKJ
Protector, Inc.
Dental · 456d
Cleared Feb 15, 1994
MIRROR, MOUTH
K925890 · EKJ
Protector, Inc.
Dental · 456d
Cleared Feb 15, 1994
GRIPPER
K930607 · GCJ
Surgical Instrument, Inc.
General & Plastic Surgery · 375d
Cleared Feb 15, 1994
BIRD 8400TI ADULT VOLUME VENTILATOR
K930747 · CBK
Bird Products Corp.
Anesthesiology · 368d
Cleared Feb 15, 1994
P.C.A. MODULAR KNEE SYSTEM
K931214 · HSX
Howmedica Corp.
Orthopedic · 342d
Cleared Feb 15, 1994
BONE PLATE
K931244 · HRS
Acu Med, Inc.
Orthopedic · 341d
Cleared Feb 15, 1994
CSD 200/300/400/500 DYNAMOMETER
K931321 · LBB
John Chatillon & Sons, Inc.
Neurology · 336d
Cleared Feb 15, 1994
EHL PULSE GENERATOR
K931779 · FFK
Psi Medical Products, Inc.
Gastroenterology & Urology · 312d
Cleared Feb 15, 1994
BISTAT 70/70-I ELECTROSURGICAL UNIT
K933131 · GEI
Medical and Scientific Enterprises, Inc.
General & Plastic Surgery · 232d
Cleared Feb 15, 1994
PROMED BIOPSY NEEDLE
K933364 · DWO
Vlv Associates, Inc.
General & Plastic Surgery · 221d