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
81481–81504 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 22, 2000
TRANSONIC HEMODIALYSIS FLOW REVERSER, MODEL B FLOWREV
K002816 · KOC
Transonic Systems, Inc.
Gastroenterology & Urology · 72d
Cleared Nov 22, 2000
MODEL 6900GE-64: C-SPINE ARRAY
K002860 · MOS
Midwest Rf, LLC
Radiology · 70d
Cleared Nov 22, 2000
GIMBEL PUNCTURE RESISTANT LATEX SURGICAL GLOVE WITH PUNCTURE RESISTANCE...
K003063 · KGO
Gimbel Glove Co., LLC
General Hospital · 51d
Cleared Nov 22, 2000
MICROMANIPULATOR
K003142 · MQJ
Research Instruments , Ltd.
Obstetrics & Gynecology · 43d
Cleared Nov 22, 2000
VINYL, POWDER-FREE, PATIENT EXAMINATION GLOVES, YELLOW
K003197 · LYZ
Kaohsiung Brothers Products Corp.
General Hospital · 41d
Cleared Nov 22, 2000
MO-202D THREE-AXIS HANGING JOYSTICK OIL HYDRAULIC MICROMANIPATOR
K003300 · MQJ
Narishige Co., Ltd.
Obstetrics & Gynecology · 33d
Cleared Nov 22, 2000
IM-5A INJECTOR
K003302 · MQJ
Narishige Co., Ltd.
Obstetrics & Gynecology · 33d
Cleared Nov 22, 2000
IM-5B MICROINJECTOR
K003303 · MQJ
Narishige Co., Ltd.
Obstetrics & Gynecology · 33d
Cleared Nov 22, 2000
IM-6 MICROINJECTOR
K003304 · MQJ
Narishige Co., Ltd.
Obstetrics & Gynecology · 33d
Cleared Nov 22, 2000
C. DIFFICILE TOX A/B II
K003306 · LLH
Techlab, Inc.
Microbiology · 33d
Cleared Nov 22, 2000
DERMAGRIP POWDER FREE PINK POLYMER COATED LATEX EXAMINATION GLOVE,...
K003307 · LYY
Wrp Specialty Products Sdn. Bhd.
General Hospital · 30d
Cleared Nov 22, 2000
DERMAGRIP POWDER FREE GREEN POLYMER COATED EXAMINATION GLOVES CONTAINS 50...
K003309 · LYY
Wrp Specialty Products Sdn. Bhd.
General Hospital · 30d
Cleared Nov 22, 2000
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH ALOE VERA,...
K003321 · LYZ
Shanghai Antares Industries, Inc.
General Hospital · 29d
Cleared Nov 22, 2000
MODIFICATION TO S.M.A.R.T NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K003336 · FGE
Cordis Corp.
Gastroenterology & Urology · 28d
Cleared Nov 22, 2000
MEDLINE ALOE TOUCH STERILE NITRILE EXAMINATION GLOVES WITH ALOE VERA
K003353 · LZA
Medline Industries, Inc.
General Hospital · 27d
Cleared Nov 22, 2000
S.M.A.R.T NITINOL STENT ENDOSOPIC BILLARY SYSTEM (VARIOUS)
K003365 · FGE
Cordis Corp.
Gastroenterology & Urology · 26d
Cleared Nov 22, 2000
JAMSHIDI MARROW ACQUISITION CRADLE
K003370 · KNW
Allegiance Healthcare Corp.
Gastroenterology & Urology · 23d
Cleared Nov 22, 2000
VOLUSON 730 DIAGNOSTIC ULTRASOUND SYSTEM
K003525 · IYN
Medison America, Inc.
Radiology · 7d
Cleared Nov 21, 2000
ROSETTA-LT/ROSETTA-RX
K002089 · DRG
General Devices
Cardiovascular · 133d
Cleared Nov 21, 2000
SINUSCOPE AND BACCESSORIES
K002214 · EOB
Pollux Endoscopy, Inc.
Ear, Nose, Throat · 120d
Cleared Nov 21, 2000
PURESPERM WASH
K002630 · MQL
Nidacon International AB
Obstetrics & Gynecology · 90d
Cleared Nov 21, 2000
SILMAX PECTORAL IMPLANT
K002633 · MIC
Pillar Surgical, Inc.
General & Plastic Surgery · 90d
Cleared Nov 21, 2000
ARAMIS DERMATOLOGICAL LASER
K002649 · GEX
Palomar Medical Technologies, Inc.
General & Plastic Surgery · 89d
Cleared Nov 21, 2000
O-PERM 30
K002703 · HQD
Optical Polymer Research, Inc.
Ophthalmic · 83d