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
105073–105096 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 27, 1994
EUROMEDICAL POLY TRACHEOTOMY TUBE
K945874 · JOH
Regulatory & Marketing Services, Inc.
Anesthesiology · 26d
Cleared Dec 27, 1994
DIRECT VIEW 2001 FIBERLIGHT
K945901 · CCW
Mercury Medical
Anesthesiology · 25d
Cleared Dec 27, 1994
TRIGUARD(TM) SUCTION SYSTEM
K945950 · BSY
Vital Signs, Inc.
Anesthesiology · 21d
Cleared Dec 27, 1994
MERIDIAN MEDICAL SYSTEMS MAPLESON D AND MODIFIED JACKSON REESE CIRCUITS
K945984 · CAI
Meridian Medical Systems, Inc.
Anesthesiology · 19d
Cleared Dec 27, 1994
DISPOSABLE GAS SAMPLING LINES
K946044 · CCK
Catheter Research, Inc.
Anesthesiology · 15d
Cleared Dec 23, 1994
TRI-MED QUICK-STEP GASTRIC LAVAGE TUBE SIZES 18FR, 22FR, 32FR
K934348 · BSS
Tri-Med Specialties, Inc.
Gastroenterology & Urology · 472d
Cleared Dec 23, 1994
MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550M PUMP SPEED CONTROLLER
K936091 · DWA
Medtronic Bio-Medicus, Inc.
Cardiovascular · 366d
Cleared Dec 23, 1994
SUPERSENSOR MRI COIL
K941582 · LNH
Superconductor Technologies, Inc.
Radiology · 267d
Cleared Dec 23, 1994
FUJI FCR IMAGE PROCESSING UNIT IP-U515
K942561 · IXK
Fujifilm Medical System U.S.A., Inc.
Radiology · 206d
Cleared Dec 23, 1994
SMARTDOP 30 BI-DIRECTIONAL BLOOD FLOW DETECTOR
K942613 · DPW
Koven Technology, Inc.
Radiology · 204d
Cleared Dec 23, 1994
ULTIMAT-SENSOR FOR BED OCCUPANCY MONITOR
K942770 · KMI
Ultimate Development Corp.
General Hospital · 193d
Cleared Dec 23, 1994
TUNGSTEN EYESHIELD
K943011 · IWS
Medtec, Inc.
Radiology · 182d
Cleared Dec 23, 1994
CIRCU-FLATE 5000 PRESSURE RELIEF SYSTEM
K943097 · FNM
Global Medical Technologies, Inc.
General Hospital · 178d
Cleared Dec 23, 1994
FIELD ABUTMENT WEDGE
K943343 · IXI
Medtec, Inc.
Radiology · 164d
Cleared Dec 23, 1994
BEHIND THE EAR HEARING AID
K944039 · ESD
Audicraft Hearing Instruments
Ear, Nose, Throat · 127d
Cleared Dec 23, 1994
BTP-A HEARING SYSTEM
K944043 · ESD
Resound Corp.
Ear, Nose, Throat · 127d
Cleared Dec 23, 1994
RIT 531 TELERADIOLOGY/ PAC SYSTEM
K944130 · LMD
Radiological Imaging Technology, Inc.
Radiology · 121d
Cleared Dec 23, 1994
COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE FUNCTION
K944720 · KPS
Nuccardiac Software, Inc.
Radiology · 91d
Cleared Dec 23, 1994
GAUZE SPONGES
K944879 · GDY
Clinical Resources, Inc.
General & Plastic Surgery · 81d
Cleared Dec 23, 1994
FLUFF GAUXZE ROLL
K945019 · EFQ
Clinical Resources, Inc.
General & Plastic Surgery · 72d
Cleared Dec 23, 1994
FLUFF GAUZE SPONGE
K945020 · EFQ
Clinical Resources, Inc.
General & Plastic Surgery · 72d
Cleared Dec 23, 1994
FLUFF GAUZE SPONGE
K945021 · EFQ
Clinical Resources, Inc.
General & Plastic Surgery · 72d
Cleared Dec 23, 1994
CHAKOFF ENDOSCOPY
K945421 · FDG
Stephen Chakoff, Inc.
Gastroenterology & Urology · 49d
Cleared Dec 23, 1994
GENERAL ANESTHESIA SYSTEM
K945455 · BTR
Vital Signs, Inc.
Anesthesiology · 46d