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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
105745–105768 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 14, 1994
ARTHREX GRAFT HARVESTING KIT
K941285 · KIJ
Arthrex, Inc.
Orthopedic · 242d
Cleared Nov 14, 1994
KRONNER LAPAROSCOPIC HOLDER
K941348 · GCJ
Kronner Prototypes, Inc.
General & Plastic Surgery · 238d
Cleared Nov 14, 1994
BI-TEC ENDOSCOPIC BIPOLAR INSTRUMENTS
K942077 · GEI
Linvatec Corp.
General & Plastic Surgery · 199d
Cleared Nov 14, 1994
ACUTOME 2000 COLOR-CORRECTED LAPAROSCOPIC C02 LASER COUPLER AND SLEEVES
K942868 · GEX
Reliant Laser Corp.
General & Plastic Surgery · 150d
Cleared Nov 14, 1994
ULTRAPRO WORKSTATION
K942917 · LMD
Ramsoft, Inc.
Radiology · 146d
Cleared Nov 14, 1994
HOT BIOPSY FORCEPS
K943078 · KGE
Intl. Medical, Inc.
Gastroenterology & Urology · 139d
Cleared Nov 14, 1994
RETINA FLOWMETER
K943955 · HLI
Heidelberg Engineering
Ophthalmic · 91d
Cleared Nov 14, 1994
RETINA TOMOGRAPH AND FLOWMETER
K943956 · HLI
Heidelberg Engineering
Ophthalmic · 91d
Cleared Nov 14, 1994
OLYMPUS SWITCHING UNIT MODEL SU-1
K944081 · FET
Olympus America, Inc.
Gastroenterology & Urology · 84d
Cleared Nov 14, 1994
ABBOTT A-GENT LIQUID MAGNESIUM REAGENT, MODIFIED
K944202 · JGJ
Abbott Laboratories
Chemistry · 95d
Cleared Nov 14, 1994
RETINA ANGIOGRAPH
K944261 · HLI
Heidelberg Engineering
Ophthalmic · 74d
Cleared Nov 14, 1994
ROYAL PLASTIC SUNGLASSES
K944341 · HQY
Royal Plastic Sarl
Ophthalmic · 69d
Cleared Nov 14, 1994
REXPLUS PP3
K944548 · ESD
Rexton, Inc.
Ear, Nose, Throat · 59d
Cleared Nov 14, 1994
NIL
K944641 · HQZ
Max-Vision (H.K.)Limited
Ophthalmic · 54d
Cleared Nov 14, 1994
SCIMED VIPER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER
K944815 · LIT
Scimed Life Systems, Inc.
Cardiovascular · 46d
Cleared Nov 14, 1994
MODEL 5151
K944821 · GCT
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 46d
Cleared Nov 14, 1994
GENERAL ANESTHESIA SYSTEM
K944949 · BTK
Vital Signs, Inc.
Anesthesiology · 38d
Cleared Nov 14, 1994
MONOJECT BONE MARROW BIOPSY TRAYS
K945109 · GAA
Sherwood Medical Co.
General & Plastic Surgery · 27d
Cleared Nov 14, 1994
PARACENTESIS NEEDLES/CANNULAS
K945160 · LRO
Tri-Med Specialties, Inc.
General & Plastic Surgery · 24d
Cleared Nov 10, 1994
HGM ILLUMINATING/ASPIRATING ENDOOCULAR PROBE
K931072 · HJM
Hgm, Inc.
Ophthalmic · 618d
Cleared Nov 10, 1994
LIFECARE CPAP-200
K933947 · BZD
Lifecare International,Inc.
Anesthesiology · 455d
Cleared Nov 10, 1994
REP DIRECT-SEP CHOLESTEROL-15 KIT
K935162 · JHO
Helena Laboratories
Chemistry · 377d
Cleared Nov 10, 1994
GEMSCOM SERIES 5000,
K935839 · DRG
General Devices
Cardiovascular · 338d
Cleared Nov 10, 1994
CONTINUOUS POSITIVE AIRWAY PRESSURE CPAP SYSTEM
K935979 · BZD
Devilbiss Health Care, Inc.
Anesthesiology · 332d