Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
82561–82584 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 20, 2000
MODEL 8500, HAND HELD PULSE OXIMETER, MODEL 8500
K001930 · DQA
Nonin Medical, Inc.
Anesthesiology · 24d
Cleared Jul 20, 2000
TORNIER CEMENT RESTRICTOR
K001932 · JDI
Tornier
Orthopedic · 24d
Cleared Jul 20, 2000
REBAR MICRO CATHETER: REBAR-18 [2.3F], 110 CM, 130 CM, 153 CM, SINGLE MARKER...
K001966 · KRA
Micro Therapeutics, Inc.
Cardiovascular · 22d
Cleared Jul 20, 2000
ABBOTT ACCLAIM ENCORE STANDARD TUBING PUMP
K002126 · FRN
Abbott Laboratories
General Hospital · 6d
Cleared Jul 20, 2000
MEDI-CULT UNIVERSAL IVF-MEDIUM
K991279 · MQL
Medicult A/S
Obstetrics & Gynecology · 463d
Cleared Jul 20, 2000
BOOKER BOX, MODEL PAD 5010
K993205 · LDD
Tz Medical, Inc.
Cardiovascular · 300d
Cleared Jul 19, 2000
LA PERSONAL SCOOTER
K000869 · INI
Assembled Products Corp.
Physical Medicine · 124d
Cleared Jul 19, 2000
THERMAGE THERMACOOL SYSTEM
K000944 · GEI
Thermage, Inc.
General & Plastic Surgery · 118d
Cleared Jul 19, 2000
JILCO TRACTION-FLEXION CHAIR
K001361 · ITH
Jilco Enterprises
Physical Medicine · 82d
Cleared Jul 19, 2000
O-LAS OPHTHALMIC PHOTODISRUPTOR
K001511 · GEX
A.R.C. Laser AG
General & Plastic Surgery · 65d
Cleared Jul 19, 2000
KSEA BIPOLAR COAGULATING ELECTRODES
K001630 · GWG
Karl Storz Endoscopy
Neurology · 54d
Cleared Jul 19, 2000
REDON SET
K001716 · JCX
Pfm Produkte Fur Die Medizin AG
General & Plastic Surgery · 44d
Cleared Jul 19, 2000
COOL-TEC ELECTRODES
K001723 · GEI
Seedling Enterprises., LLC
General & Plastic Surgery · 43d
Cleared Jul 19, 2000
LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM (FAMILY OF PRODUCTS)
K001746 · GEX
Coherent Star
General & Plastic Surgery · 41d
Cleared Jul 19, 2000
MEDIS 2MP2 QUAD-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM
K001751 · LLZ
Barco NV Display Systems
Radiology · 41d
Cleared Jul 19, 2000
MEDIS 55MP1H SINGLE-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM
K001752 · LLZ
Barco NV Display Systems
Radiology · 41d
Cleared Jul 19, 2000
MEDIS 5MP1H DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM
K001754 · LLZ
Barco NV Display Systems
Radiology · 41d
Cleared Jul 19, 2000
MODIFICATION TO CENTAUR SPINAL SYSTEM
K001844 · KWQ
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Jul 19, 2000
ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD
K001936 · GEI
Arthrocare Corp.
General & Plastic Surgery · 23d
Cleared Jul 19, 2000
MICROVASIVE LITHOTRIPTOR FLEXPROBE II
K002084 · FFK
Boston Scientific Corp
Gastroenterology & Urology · 9d
Cleared Jul 19, 2000
CONTROL SOLUTIONS INC, MODEL CS3101
K993420 · IPF
Control Solutions, Inc.
Physical Medicine · 281d
Cleared Jul 19, 2000
SPINAL PAD
K993684 · ILY
Bioscan, Inc.
Physical Medicine · 261d
Cleared Jul 19, 2000
NANMA VACUUM PUMP
K993909 · LKY
Nanma Mfg Co., Ltd.
Gastroenterology & Urology · 245d
Cleared Jul 19, 2000
GEM KNEE SYSTEM
K994214 · JWH
Kinamed, Inc.
Orthopedic · 218d