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
133225–133248 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 24, 1989
ATS TB RAPID STAIN SET PRODUCT #034-45
K890148 · ICL
Alpha-Tec Systems, Inc.
Pathology · 11d
Cleared Jan 23, 1989
CLINISTAT BUN (BLOOD UREA NITROGEN) REAGENT TEST
K883327 · JGZ
Heraeus Kulzer, Inc.
Chemistry · 168d
Cleared Jan 23, 1989
ALBUWELL
K884146 · JIR
Exocell, Inc.
Chemistry · 112d
Cleared Jan 23, 1989
TECHNICON SYSTEM RA-100/ASSIST MAGNESIUM
K884600 · JGJ
Technicon Instruments Corp.
Chemistry · 81d
Cleared Jan 23, 1989
TOTAL PROTEIN TEST (TP) ITEM #65670
K884703 · CEK
Em Diagnostic Systems, Inc.
Chemistry · 75d
Cleared Jan 23, 1989
URIC ACID TEST (URIC) ITEM #65620
K884704 · KNK
Em Diagnostic Systems, Inc.
Chemistry · 75d
Cleared Jan 23, 1989
28 ADDITIONAL ALLERGEN MODULES FOR ALASTAT(TM)
K884883 · DHB
Diagnostic Products Corp.
Immunology · 62d
Cleared Jan 23, 1989
COAT-A-COUNT (TM) THEOPHYLLINE
K890002 · KLS
Diagnostic Products Corp.
Toxicology · 20d
Cleared Jan 23, 1989
NEW LOW LEVEL DRUG MIXTURE CONTROL
K890030 · DIF
Rapid Diagnostic Laboratories, Inc.
Toxicology · 19d
Cleared Jan 23, 1989
V-TREND TARGET IM TEST
K890041 · KTN
Texas Immunology, Inc.
Immunology · 18d
Cleared Jan 19, 1989
MODELS M1175A & M1176A COMPONENT MONITORING SYSTEM
K882609 · DRT
Waltham Div. Hewlett Packard
Cardiovascular · 206d
Cleared Jan 19, 1989
ARROW PNEUMOTHORAX KIT, AK-01500
K883905 · JOL
Arrow Intl., Inc.
General Hospital · 126d
Cleared Jan 19, 1989
VORTECH'S MEDICAL IMAGING GATEWAY
K884434 · LMD
Vortech Data, Inc.
Radiology · 91d
Cleared Jan 19, 1989
SPIROMETRICS MODEL 2200 SM200 FLOW SENSOR
K884464 · JAX
Spirometrics, Inc.
Anesthesiology · 87d
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