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
122809–122832 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 18, 1991
ACS ANGIOSCOPIC CATHETER
K905715 · DQO
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 87d
Cleared Mar 18, 1991
CUSTOM ITE HEARING AID
K905784 · ESD
Hearing Aid Co.
Ear, Nose, Throat · 90d
Cleared Mar 18, 1991
DOSE CALIBRATOR
K905796 · KPT
Capintec Instruments, Inc.
Radiology · 81d
Cleared Mar 18, 1991
ABRA MODEL LINE LOW DRAIN CUST IN-THE-EAR HEAR AID
K910311 · ESD
Ototech, Ltd.
Ear, Nose, Throat · 53d
Cleared Mar 18, 1991
C ABRA MODEL LINEAR, LOW DRAIN CUST CANAL HEAR AID
K910312 · ESD
Ototech, Ltd.
Ear, Nose, Throat · 53d
Cleared Mar 18, 1991
ABRA IPC MODEL INPUT COMPRES AGCCUST ITE HEAR AID
K910313 · ESD
Ototech, Ltd.
Ear, Nose, Throat · 53d
Cleared Mar 18, 1991
C ABRA MODEL LINEAR, LOW DR. CUSTOM CANAL HEAR AID
K910314 · ESD
Ototech, Ltd.
Ear, Nose, Throat · 53d
Cleared Mar 18, 1991
MEGA LACERATION KIT
K910368 · LRO
Megadyne Medical Products, Inc.
General & Plastic Surgery · 48d
Cleared Mar 15, 1991
KEVTEK LASER-STOP ENDOTRACHEAL TUBE LASER-STOP
K902193 · BTR
Kevtek Medical Products, Inc.
Anesthesiology · 303d
Cleared Mar 15, 1991
WIRON 99 DENTAL CASTING ALLOY
K903538 · EJH
Leach and Dillon Co., Inc.
Dental · 220d
Cleared Mar 15, 1991
DYNATRON 200 MICROCURRENT
K903577 · GZJ
Dynatronics Corp.
Neurology · 219d
Cleared Mar 15, 1991
STERAID DISPOSABLE SYRINGE
K904620 · FMF
Disposable Medi-Aids , Ltd.
General Hospital · 155d
Cleared Mar 15, 1991
BALLOON CATHETERS
K904669 · FGE
Olympus Corp.
Gastroenterology & Urology · 151d
Cleared Mar 15, 1991
BC-1201 CAST ABUTMENT
K904703 · DZE
Minimatic Implant Technology
Dental · 150d
Cleared Mar 15, 1991
MATRICS
K904756 · ESD
Kerr Corporation (Danbury)
Ear, Nose, Throat · 147d
Cleared Mar 15, 1991
MOTOR DRIVEN EXTIRPATION INSTRUMENTS
K904859 · HRX
Aesculap, Inc.
Orthopedic · 137d
Cleared Mar 15, 1991
PLAYTEX ULTIMATES UNSCENTED AND SCENTED TAMPONS
K904937 · HEB
Playtex Family Products, Inc.
Obstetrics & Gynecology · 134d
Cleared Mar 15, 1991
ACETATE CONCENTRATES FOR HEMODIALYSIS
K905021 · KPO
Medical Components, Inc.
Gastroenterology & Urology · 128d
Cleared Mar 15, 1991
MOUSSE, POLYVINYL SILOXANE IMPRESSION MATERIAL
K905032 · ELW
Parkell
Dental · 128d
Cleared Mar 15, 1991
NERVE LOCATOR/STIMULATOR
K905045 · ETN
Aaron Medical Industries
Ear, Nose, Throat · 127d
Cleared Mar 15, 1991
INJECTOR, INSULIN
K905062 · KZE
Sound 2000 Medical Systems, Inc.
General Hospital · 126d
Cleared Mar 15, 1991
SENTRY SCALE
K905122 · FRW
Apollo Enterprise, Ltd. Co.
General Hospital · 121d
Cleared Mar 15, 1991
DURAFILL COLOR VS
K905131 · EBF
Kulzer, Inc.
Dental · 120d
Cleared Mar 15, 1991
FLOSCOPE VASCULAR LAB.
K905157 · JOP
Advance Medical Device, Inc.
Cardiovascular · 119d