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
108841–108864 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 12, 1994
USDT PHENCYCLIDINE (PCP) ASSAY COLUMN CAT. NO. 9000-400
K935629 · LCM
U.S. Drug Testing, Inc.
Toxicology · 140d
Cleared Apr 12, 1994
BIOSCAN REAGENT STRIPS
K940043 · JIL
Bioscan Instruments, Inc.
Chemistry · 97d
Cleared Apr 12, 1994
SPECTACLE FRAMES (WING SHING OPTICAL)
K940077 · HQZ
Continental Optical Imports
Ophthalmic · 96d
Cleared Apr 12, 1994
SUNGLASSES
K940182 · HQY
Beta Toys, Inc.
Ophthalmic · 90d
Cleared Apr 12, 1994
TRIGEL- MULTIFUNCTION ELECTRODE
K940219 · GEI
Physiometrix, Inc.
General & Plastic Surgery · 84d
Cleared Apr 12, 1994
ACUFEX VIDEO SYSTEM
K940241 · GCJ
Acufex Microsurgical, Inc.
General & Plastic Surgery · 83d
Cleared Apr 12, 1994
E.M.A.
K940613 · HQY
European Manufacturers Agency, Inc.
Ophthalmic · 57d
Cleared Apr 12, 1994
YON'S JAY ENTERPRISE CO
K940730 · HQY
Yon'S Jay Enterprise Co.
Ophthalmic · 53d
Cleared Apr 12, 1994
BAYVUE (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS
K940777 · LPL
Unilens Corp., USA
Ophthalmic · 49d
Cleared Apr 12, 1994
ARTSUN OPTICAL FRAME
K940782 · HQZ
Frontier Novelty, Inc.
Ophthalmic · 49d
Cleared Apr 12, 1994
REWINNER ENT H.K. BRANCH NON-PRESCRIPTION SUNGLASSES
K940827 · HQY
Rainbow Merchandise, Inc.
Ophthalmic · 49d
Cleared Apr 12, 1994
NIL
K940846 · HQY
Evergreat Optical Ind Co., Ltd.
Ophthalmic · 48d
Cleared Apr 12, 1994
MORRISON FRAME, SPECTACLE
K940853 · HQZ
Morrison Center
Ophthalmic · 48d
Cleared Apr 12, 1994
SPECTACLE FRAMES/SUNGLASSES
K941051 · HQY
Europa/Encore Eyewear
Ophthalmic · 40d
Cleared Apr 12, 1994
EYEGLASS SPECTACLE FRAMES VARIOUS COLLECTIONS
K941052 · HQZ
Atlantic Optical Co., Inc.
Ophthalmic · 40d
Cleared Apr 12, 1994
NON-PRESCRIPTION SUNGLASSES
K941055 · HQY
Kingsun Optical Ent. Co., Ltd.
Ophthalmic · 40d
Cleared Apr 12, 1994
FRONTIER NOVELTY DAELIM OPTICAL FRAME
K941059 · HQZ
Frontier Novelty, Inc.
Ophthalmic · 35d
Cleared Apr 12, 1994
SUNGLASSES AND SPORT SUNGLASSES
K941076 · HQY
20/20 Ent.
Ophthalmic · 35d
Cleared Apr 12, 1994
SPLASHMASTER OC EYE AND FACE PROTECTIVE PRODUCTS
K941147 · HQY
Cabot Safety Corp.
Ophthalmic · 33d
Cleared Apr 11, 1994
BIOCHEM MODEL 3302 NEWOX2 OXIMETER
K920083 · DQA
Biochem International, Inc.
Anesthesiology · 825d
Cleared Apr 11, 1994
PRESTYL JET INJECTOR
K922683 · EJI
Bma Technologies S.A.
Dental · 676d
Cleared Apr 11, 1994
LAPAROSCOPY SETS, NEEDLE HOLDERS, BLUNT SHEARS
K923259 · HET
Imtec Corp.
Obstetrics & Gynecology · 648d
Cleared Apr 11, 1994
STERILE CONVERTORS SMS POLYPROPYLENE GOWN & DRAPE
K924101 · KKX
Baxter Healthcare Corp
General Hospital · 606d
Cleared Apr 11, 1994
A-DEC 7284 CUSPIDOR, CASCADE
K925367 · EBR
A-Dec, Inc.
Dental · 537d