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
135457–135480 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 06, 1988
MULTICOR AND PACEMAKERS
K880898 · DXY
Tpl-Cordis, Inc.
Cardiovascular · 70d
Cleared May 06, 1988
BARD (R) ESKA ERECTIOMETER
K880903 · LIL
C.R. Bard, Inc.
Gastroenterology & Urology · 65d
Cleared May 06, 1988
NATELSON TUBES, HEPARIN AND PLAIN
K881187 · GIO
Helps Products, Inc.
Hematology · 46d
Cleared May 06, 1988
CARAWAY TUBES, HEPARIN AND PLAIN
K881262 · GIO
Helps Products, Inc.
Hematology · 43d
Cleared May 06, 1988
CLP ABNORMAL COAGULATION CONTROL
K881510 · GGC
Creative Laboratory Products, Inc.
Hematology · 25d
Cleared May 06, 1988
HR(TM) INTRAVASCULAR CATHETER
K881666 · FOZ
Icu Medical, Inc.
General Hospital · 18d
Cleared May 04, 1988
CADWELL EXCEL
K880088 · GWF
Cadwell Laboratories, Inc.
Neurology · 113d
Cleared May 04, 1988
SINGLE PHASE DIAG. X-RAY GENERATOR MICRO-X 650
K880519 · IZO
Fischer Imaging Corp.
Radiology · 85d
Cleared May 04, 1988
SINGLE PHASE DIAGNOSTIC X-RAY GENERATOR FX-650
K880521 · IZO
Fischer Imaging Corp.
Radiology · 85d
Cleared May 04, 1988
THREE PHASE, DIAGNOSTIC X-RAY GENERATOR MICRO-X 80
K880522 · IZO
Fischer Imaging Corp.
Radiology · 85d
Cleared May 04, 1988
THREE PHASE, DIAGNOSTIC GENERATOR MICRO-X 75
K880523 · IZO
Fischer Imaging Corp.
Radiology · 85d
Cleared May 04, 1988
THREE PHASE DIAGNOSTIC X-RAY GENERATOR MICRO-X 100
K880524 · IZO
Fischer Imaging Corp.
Radiology · 85d
Cleared May 04, 1988
MODIFIED IMIPENEM SUSCEPTIBILITY POWDER
K880574 · JTT
Merck, Sharp & Dohme
Microbiology · 84d
Cleared May 04, 1988
ARTUS DISPOSABLE SHEATHS/CUTTERS
K880881 · HSZ
Acufex Microsurgical, Inc.
Orthopedic · 63d
Cleared May 04, 1988
VENTRICULAR BOLT PRESSURE MONITORING KIT #110-4H
K881183 · GWM
Camino Laboratories, Inc.
Neurology · 44d
Cleared May 04, 1988
HR-5000 ELECTROSURGICAL DEVICE FOR NEW INDICATIONS
K881276 · KCW
Ime Co. , Ltd.
General & Plastic Surgery · 40d
Cleared May 04, 1988
DURADERM BUTTERFLY
K881343 · GXY
Sentry Medical Products, Inc.
Neurology · 35d
Cleared May 04, 1988
DIDECO-SHILEY FEED TUBE SUPPORT ARMS AND HOOK
K881421 · CAC
Shiley, Inc.
Anesthesiology · 30d
Cleared May 04, 1988
SMOKEVAC ELECTORSURGICAL PENCIL
K881460 · GEI
Byron Medical
General & Plastic Surgery · 27d
Cleared May 04, 1988
BIOFRAGMENTABLE BOWEL ANASTOMOSIS RING
K881484 · GDW
Davis & Geck, Inc.
General & Plastic Surgery · 26d
Cleared May 04, 1988
SDL TRICHROME STAIN
K881598 · JTS
Scientific Device Laboratory, Inc.
Pathology · 21d
Cleared May 04, 1988
ULTRA TRACTION
K881603 · ITH
Component Equipment Mfg., Inc.
Physical Medicine · 21d
Cleared May 04, 1988
EASY TENS
K881704 · GZJ
American Imex
Neurology · 15d
Cleared May 04, 1988
ROLLS 2000 SERIES WHEELCHAIR
K881762 · IOR
Invacare Corp.
Physical Medicine · 12d