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
136057–136080 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 03, 1988
SUREDROP EYEDROP GUIDE
K874569 · JYJ
Suredrop, Inc.
Ear, Nose, Throat · 180d
Cleared May 03, 1988
ILLUMINATING INFUSION CONTACT LENS FOR EYE SURGERY
K874591 · HPX
Vitreo Dynamics, Co.
Ophthalmic · 176d
Cleared May 03, 1988
OCU-1
K875030 · HMX
Rudolph Beaver, Inc.
Ophthalmic · 148d
Cleared May 03, 1988
ULTRASOUND DIATHERMY UNIT ULTRASOUND HEATER
K875381 · IMI
Ford Laboratories, Inc.
Physical Medicine · 148d
Cleared May 03, 1988
CYSTOTOMES/KNIFES
K880345 · HNY
Myocure, Inc.
Ophthalmic · 98d
Cleared May 03, 1988
CANNULAS
K880346 · HMX
Myocure, Inc.
Ophthalmic · 98d
Cleared May 03, 1988
ANESTHESIA/RETROBULBAR NEEDLES
K880347 · HMX
Myocure, Inc.
Ophthalmic · 98d
Cleared May 03, 1988
BLUE PLASTIC EYE SHIELD
K880490 · HOY
Eye Garter Company, Inc.
Ophthalmic · 89d
Cleared May 03, 1988
MEDSURG 7 FR. DUAL LUMEN CENTRAL VEIN CATH SYSTEM
K880771 · DQR
Medsurg Industries, Inc.
Cardiovascular · 67d
Cleared May 03, 1988
MODEL PC ARGON LASER
K880908 · GEX
Hgm, Inc.
General & Plastic Surgery · 61d