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
132649–132672 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 19, 1989
AIR-ELECTRONIC AIR CLEANER (FILTER)
K884472 · FRF
White-Rodgers, Div. Emerson Electric Co.
General Hospital · 86d
Cleared Jan 19, 1989
ETV, ELECTRONIC VISION AID
K884540 · HPE
Sevrain-Tech, Inc.
Ophthalmic · 83d
Cleared Jan 19, 1989
ATI-PYMAH DISPOSABLE STEAM BIOLOGICAL TEST PACK
K884615 · FRC
Pymah Corp., Ati Div.
General Hospital · 76d
Cleared Jan 19, 1989
RACESTYPTINE
K884653 · EKJ
Specialites Septodont
Dental · 73d
Cleared Jan 19, 1989
KETAC-GLAZE
K884752 · KLE
Espe GmbH (Us)
Dental · 66d
Cleared Jan 19, 1989
DISCARD DENTAL EXPLORER
K885217 · EKJ
Wen Hao, Inc.
Dental · 31d
Cleared Jan 19, 1989
DISCARD DENTAL MIRROR
K885218 · EKJ
Wen Hao, Inc.
Dental · 31d
Cleared Jan 19, 1989
DENTAL DRESSING PLIERS
K885219 · EKJ
Wen Hao, Inc.
Dental · 31d
Cleared Jan 18, 1989
OMNIFIT TOTAL KNEE SERIES III,IV & POST. STAB. FEM
K884410 · JWH
Osteonics Corp.
Orthopedic · 90d
Cleared Jan 18, 1989
CRUCIOMETER
K884483 · JZE
Orthopedic Systems, Inc.
Ear, Nose, Throat · 85d
Cleared Jan 18, 1989
ALTA NON-REAMED TIBIAL ROD
K884500 · HSB
Howmedica Corp.
Orthopedic · 84d
Cleared Jan 18, 1989
USCI 8F EXTRA LARGE LUMEN GUIDE CATHETER
K884502 · DQO
C.R. Bard, Inc.
Cardiovascular · 84d
Cleared Jan 18, 1989
BTE HEARING AID SIEMENS MODEL 284PP-ASP
K884583 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 77d
Cleared Jan 18, 1989
EXEL 1800 AND 1800E CT SCANNER
K884670 · JAK
Elscint, Inc.
Radiology · 71d
Cleared Jan 18, 1989
EXEL 2400 AND 2400 ELITE CT SCANNERS
K884671 · JAK
Elscint, Inc.
Radiology · 71d
Cleared Jan 18, 1989
NON-STERILE VINYL GLOVES
K885346 · FMC
Daw Shin Industrial Co., Ltd.
General Hospital · 21d
Cleared Jan 17, 1989
CURIETRON 192 LOW DOSE RATE
K881323 · JAQ
Compagnie Oris Industrie, S.A.
Radiology · 295d
Cleared Jan 17, 1989
TAKEDA MEDICAL AUTO. DIGITAL BLOOD PRES. MONITOR
K882824 · DXN
A&D Engineering, Inc.
Cardiovascular · 193d
Cleared Jan 17, 1989
TAKEDA MEDICAL AUTO. DIG. BLOOD PRES. METER W/PRIN
K882825 · DXN
A&D Engineering, Inc.
Cardiovascular · 193d
Cleared Jan 17, 1989
MINIMON 7134B PATIENT MONITOR
K883069 · DRT
Kontron Instruments, Inc.
Cardiovascular · 181d
Cleared Jan 17, 1989
MINIMON 7136B PATIENT MONITOR
K883109 · DRT
Kontron, Inc.
Cardiovascular · 176d
Cleared Jan 17, 1989
THORACIC SUPPORT SYSTEM
K883214 · KMO
Storer Medical Products
General Hospital · 172d
Cleared Jan 17, 1989
EXCALIBUR CONTROLLER (WORK LOAD PROGRAMMER)
K883402 · DPS
Quinton, Inc.
Cardiovascular · 166d
Cleared Jan 17, 1989
E550 ELECTROCARDIOGRAPH
K883440 · DSI
Burdick Corp.
Cardiovascular · 155d