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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
52657–52680 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 30, 2009
NOVAPRO STRETCH VINYL EXAMINATION GLOVE POWDER FREE (YELLOW/WHITE)
K091422 · LYZ
Novapro Co., Ltd.
General Hospital · 78d
Cleared Jul 30, 2009
RECRUIT MICROCATHETER
K091563 · MMX
Reverse Medical Corporation
Cardiovascular · 63d
Cleared Jul 30, 2009
POWDERED VINYL PATIENT EXAMINATION GLOVES
K091662 · LYZ
Zhangjiagang Fengyuan Plastic...
General Hospital · 51d
Cleared Jul 30, 2009
TDS ZIRCONIA ABUTMENT FOR NOBEL BIOCARE BRANEMARK
K091693 · NHA
Pou YU Biotechnology Co., Ltd.
Dental · 50d
Cleared Jul 30, 2009
NEOSALUS LOTION
K091719 · FRO
Quinnova Pharmaceuticals
General & Plastic Surgery · 49d
Cleared Jul 30, 2009
MODIFIED CONCENTRIC MICROCATHETER, MODEL 90047
K091961 · DQO
Concentric Medical, Inc.
Cardiovascular · 29d
Cleared Jul 30, 2009
ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076-6040, 2092-6040, 2105-6040
K091966 · PNO
Angioscore, Inc.
Cardiovascular · 29d
Cleared Jul 30, 2009
MODIFICATION TO: INTERFUSE INTERVERTEBRAL BODY FUSION DEVICE , MODEL 9076
K091988 · MAX
Vertebral Technologies, Inc.
Orthopedic · 28d
Cleared Jul 30, 2009
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7962
K091997 · DXN
Andon Health Co, Ltd.
Cardiovascular · 28d
Cleared Jul 30, 2009
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM
K092015 · HRS
Smith & Nephew, Inc.
Orthopedic · 24d
Cleared Jul 30, 2009
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-738 AND KD-739
K092045 · DXN
Andon Health Co, Ltd.
Cardiovascular · 24d
Cleared Jul 30, 2009
AMERIGEL WOUND DRESSING PLUS 1/2 OZ. (15G TUBE), MODEL A2025
K092086 · SEJ
Amerx Health Care Corp.
General & Plastic Surgery · 21d
Cleared Jul 29, 2009
BULLSEYE BILIARY STENT SYSTEM
K082093 · FGE
Squareone
Gastroenterology & Urology · 370d
Cleared Jul 29, 2009
NEUROSIGN AVALANCHE MOTOR NERVE MONITOR
K083242 · ETN
The Magstim Company , Ltd.
Ear, Nose, Throat · 268d
Cleared Jul 29, 2009
POWDER FREE BLUE LATEX PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH...
K083409 · LZC
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 253d
Cleared Jul 29, 2009
ATLAS IMPLANT SYSTEM - WIDE PLUS
K090054 · DZE
Cowellmedi Co., Ltd.
Dental · 202d
Cleared Jul 29, 2009
MODIFICATION TO OLYMPUS CAPSULE ENDOSCOPE SYSTEM
K090210 · NEZ
Olympus Medical Systems Corporation
Gastroenterology & Urology · 182d
Cleared Jul 29, 2009
PONTO PRO
K090996 · LXB
Oticon Medical AB
Ear, Nose, Throat · 112d
Cleared Jul 29, 2009
PLANMECA PROSENSOR
K091197 · EHD
Planmeca Oy
Radiology · 97d
Cleared Jul 29, 2009
MOD1T COMPENSATORS FOR RADIATION BEAM THERAPY
K091403 · IXI
Oncology Tech, LLC
Radiology · 78d
Cleared Jul 29, 2009
PILLCAM PLATFORM WITH PILLCAM SB CAPSULES WITH PILLCAM SENSORBELT
K091405 · NEZ
Given Imaging , Ltd.
Gastroenterology & Urology · 78d
Cleared Jul 29, 2009
HEART-EXERCISE
K091594 · MHX
Ge Medical Systems Information...
Cardiovascular · 57d
Cleared Jul 29, 2009
PANTA NAIL (DIA. 10MM), PANTA NAIL XL
K091788 · HSB
Newdeal Sas
Orthopedic · 42d
Cleared Jul 29, 2009
MOXIE PLASTIC APPLICATOR AND MOXIE NON-APPLICATOR TAMPON
K092054 · HEB
Tosama D.D.
Obstetrics & Gynecology · 22d