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
49945–49968 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 16, 2010
RS CARE LATEX MEDICAL EXAMINATION GLOVE (POWDER FREE)
K100611 · LYY
Riverstone Resources Sdn Bhd
General Hospital · 135d
Cleared Jul 16, 2010
PEAK UNIVERSAL BOND (LIGHT CURE RESIN ADHESIVE AND CHLORHEXIDINE)
K100752 · KLE
Ultradent Products, Inc.
Dental · 121d
Cleared Jul 16, 2010
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K100964 · LYZ
Hebei Shenzichen Plastic & Rubber...
General Hospital · 100d
Cleared Jul 16, 2010
REPROCESSED RESTEP COMPRESSION SLEEVES
K101087 · JOW
Ascent Heatlhcare Solutions
Cardiovascular · 88d
Cleared Jul 16, 2010
ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 5000
K101092 · DWJ
Medivance, Inc.
Cardiovascular · 87d
Cleared Jul 16, 2010
POWDER-FREE, NATURAL COLOR, LATEX SURGICAL GLOVE, STERILE
K101102 · KGO
Best Putra Gloves Sdn Bhd
General Hospital · 87d
Cleared Jul 16, 2010
POWDERED, NATURAL COLOR, LATEX SURGICAL GLOVE, STERILE MODEL: MSP1
K101103 · KGO
Best Putra Gloves Sdn Bhd
General Hospital · 87d
Cleared Jul 16, 2010
ERBE ESU MODEL VIO 100 C WITH ACCESSORIES
K101108 · GEI
Erbe USA, Inc.
General & Plastic Surgery · 87d
Cleared Jul 16, 2010
LEV-OR DILATION CATHETER OTW
K101117 · DQY
Baylis Medical Co., Inc.
Cardiovascular · 86d
Cleared Jul 16, 2010
WATER BOTTLE CAP SYSTEM
K101146 · FEQ
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 84d
Cleared Jul 16, 2010
POWDERED VINYL PATIENT EXAMINATION GLOVES
K101343 · LYZ
Shijiazhuang Star Plastic Co., Ltd.
General Hospital · 65d
Cleared Jul 16, 2010
JULIET OL
K101720 · MAX
Spineart
Orthopedic · 28d
Cleared Jul 16, 2010
THE SONOACE R3 DIAGNOSTIC ULTRASOUND SYSTEM
K101829 · ITX
Medison Co., Ltd.
Radiology · 15d
Cleared Jul 16, 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K101840 · LYZ
Shijiazhuang Sail Plastic Co., Ltd.
General Hospital · 15d
Cleared Jul 16, 2010
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K101841 · LYZ
Shijiazhuang Sail Plastic Co., Ltd.
General Hospital · 15d
Cleared Jul 15, 2010
REMEL SPECTRA VRE
K092819 · JSO
Thermo Fisher Scientific
Microbiology · 304d
Cleared Jul 15, 2010
YEAST TRAFFIC LIGHT PNA FISH
K093024 · NZS
Advandx, Inc.
Microbiology · 289d
Cleared Jul 15, 2010
THD BANDY
K093497 · FHN
Thd Spa
Gastroenterology & Urology · 245d
Cleared Jul 15, 2010
EVGUIDE TIP LOCATION SYSTEM
K093775 · LJS
Romedex International Srl
General Hospital · 219d
Cleared Jul 15, 2010
ATS TRI-AD SEMI-FLEXIBLE TRICUSPID ANUULOPLASTY, MODEL 900SFC
K093903 · KRH
Genesee Biomedical, Inc.
Cardiovascular · 205d
Cleared Jul 15, 2010
DIABETESMANAGER SYSTEM, DIABETESMANAGER-RX SYSTEM MODEL VERSION 1.1
K100066 · MRZ
Welldoc, Inc.
General Hospital · 185d
Cleared Jul 15, 2010
LOGIFLEX LAPAROSCOPIC BAND POSITIONING DEVICE
K100109 · GCJ
Surgical Innovations Plc
General & Plastic Surgery · 182d
Cleared Jul 15, 2010
XINIWAVE, MODEL XW-18
K100441 · NUH
International Trade Group, Inc.
Neurology · 148d
Cleared Jul 15, 2010
SMITH & NEPHEW MDF MODULAR SLEEVE
K100481 · MEH
Smith & Nephew, Inc.
Orthopedic · 147d