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
49249–49272 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 18, 2010
VISTEO
K093105 · EHD
Owandy
Radiology · 382d
Cleared Oct 18, 2010
KARL STORZ ARTHROPUMP POWER IRRIGATION/SUCTION PUMP
K093471 · HRX
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 346d
Cleared Oct 18, 2010
MEDTOX BUPRENORPHINE TEST
K100951 · DJG
Medtox Diagnostics, Inc.
Chemistry · 195d
Cleared Oct 18, 2010
PMC LAPAROSCOPIC INSTRUMENTS
K101193 · GCJ
Pmc Medical GmbH
General & Plastic Surgery · 173d
Cleared Oct 18, 2010
WAVESENSE DIABETES MANAGER MODEL VERSION 1.3.4
K101597 · NBW
Agamatrix
Chemistry · 132d
Cleared Oct 18, 2010
LENSX LASER SYSTEM
K101626 · OOE
Lensx Lasers, Inc.
Ophthalmic · 131d
Cleared Oct 18, 2010
IMMUKNOW-THE CYLEX IMMUNE CELLFUNCTION ASSAY
K101911 · NID
Cylex, Inc.
Hematology · 101d
Cleared Oct 18, 2010
MODIFICATION TO:EXPEDIUM SPINE SYSTEM
K101933 · NKB
Depuy Spine, Inc.
Orthopedic · 98d
Cleared Oct 18, 2010
CARESCAPE MONITOR B650
K102239 · MHX
GE Healthcare Finland Oy
Cardiovascular · 70d
Cleared Oct 18, 2010
RE-TRACE URETERAL ACCESS SHEATH
K102485 · FED
Coloplast A/S
Gastroenterology & Urology · 49d
Cleared Oct 18, 2010
LIVEWIRE ELECTOPHYSIOLOGY CATHETER
K102721 · DRF
St Jude Medical
Cardiovascular · 27d
Cleared Oct 16, 2010
VITALOGRAPH HAND HELD SPIROMETER, MODEL 2120
K100687 · BZG
Vitalograph (Ireland) , Ltd.
Anesthesiology · 220d
Cleared Oct 16, 2010
REALSEAL XT SEALER
K102163 · KIF
Kerr Corporation
Dental · 75d
Cleared Oct 15, 2010
RANDOX BENZODIAZEPINE ASSAY
K092274 · JXM
Randox Laboratories, Ltd.
Toxicology · 444d
Cleared Oct 15, 2010
PINPOINTE FOOTLASER MODEL 6W, 30W, 100W
K093545 · GEX
Incisive, Inc. (Formerly Named...
General & Plastic Surgery · 332d
Cleared Oct 15, 2010
PINPOINTE FOOTLASER
K093547 · PDZ
Pinpointe USA, Inc.
General & Plastic Surgery · 332d
Cleared Oct 15, 2010
KAPSS SPINAL SYSTEM
K093833 · MNI
Robert Reid, Inc.
Orthopedic · 305d
Cleared Oct 15, 2010
NON-STERILE POWDER- FREE PEACH COLOR, NITRILE EXAMINATION GLOVES WITH LANO-E...
K101351 · LZA
Ascend Eagle, Inc.
General Hospital · 154d
Cleared Oct 15, 2010
PROTEGRITY SMT LATEX SURGICALGLOVES
K101811 · KGO
Cardinal Health, Inc.
General Hospital · 108d
Cleared Oct 15, 2010
ST JUDE MEDICAL MEDIGUIDE ENABLED LIVEWIRE STEERABLE ELECTROPHYSIOLOGY...
K101955 · DRF
St Jude Medical
Cardiovascular · 95d
Cleared Oct 15, 2010
RPM RESPIRATORY GATING SYSTEM
K102024 · IYE
Varian Medical Systems
Radiology · 88d
Cleared Oct 15, 2010
LDR SPINE USA SPINETUNE TL SPINAL SYSTEM
K102331 · MNI
Ldr Spine USA
Orthopedic · 59d
Cleared Oct 15, 2010
BEYONDIMAGE WORKSTATION
K102435 · LLZ
Neusoft Medical Systems Co., Ltd.
Radiology · 50d
Cleared Oct 15, 2010
TARGET DETACHABLE COIL
K102672 · HCG
Boston Scientific Corp
Neurology · 29d