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

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175,820 results
49537–49560 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 09, 2010
PACEMAKER HIGH-SPEED HANDPIECE MODEL PM-MQ, PM-M
K101551 · EFB
Delma Medical Instrument (Guangzhou)...
Dental · 97d
Cleared Sep 09, 2010
MEDTRONIC C315 DELIVERY CATHETER
K101885 · DQY
Medtronic, Inc.
Cardiovascular · 65d
Cleared Sep 08, 2010
EMS MINIMASTER LED
K093723 · ELC
E.M.S Electro Medical Systems S.A
Dental · 279d
Cleared Sep 08, 2010
STERIGAGE MODEL 1243RA, 1243RB, 1243RE
K101249 · JOJ
3M Company
General Hospital · 127d
Cleared Sep 08, 2010
ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMATED SYSTEMS, ROCHE DIAGNOSTICS...
K101456 · JIX
Roche Diagnostics
Chemistry · 105d
Cleared Sep 08, 2010
FRAXEL RE:STORE DUAL LASER SYSTEM: MODEL, MC-SYS-SR1500-D-US
K101490 · ONG
Thermage, Inc.
General & Plastic Surgery · 99d
Cleared Sep 08, 2010
NON-STERILE, POWDER FREE BLACK NITRILE EXAMINATION GLOVES WITH CHERRY FLAVOR
K101646 · LZA
Sgmp Co., Ltd.
General Hospital · 89d
Cleared Sep 08, 2010
HANDHELD PULSE OXIMETER MODEL M800
K101694 · DQA
Guangdong Biolight Meditech Co., Ltd.
Anesthesiology · 84d
Cleared Sep 08, 2010
VISIONSCOPE HIGH DEFINITION ENDOSCOPY CAMERA SYSTEM WITH
K101734 · HRX
Visionscope Technologies, LLC
Orthopedic · 79d
Cleared Sep 08, 2010
NEWPORT E360 VENTILATOR
K101803 · CBK
Newport Medical Instruments, Inc.
Anesthesiology · 72d
Cleared Sep 08, 2010
KIMBERLY-CLARK PURPLE NITRILE XTRA* STERILE POWDER-FREE EXAM GLOVE...
K102032 · LZA
Kimberly-Clark Corp.
General Hospital · 51d
Cleared Sep 08, 2010
SNORE GUARD ADVANCE
K102118 · LRK
Ranir, LLC
Dental · 42d
Cleared Sep 07, 2010
FASTCLAMP ENDOSCOPIC CLAMPING SYSTEM
K100442 · GCJ
Surgical Innovations Group Plc
General & Plastic Surgery · 202d
Cleared Sep 07, 2010
FLEXITIME XTREME 2 HEAVY TRAY CARTRIDGE REFILL, FEXITIME XTREME 2 LIGHT TRAY...
K101617 · ELW
Heraeus Kulzer, LLC
Dental · 90d
Cleared Sep 07, 2010
POWDER FREE NITRILE EXAMINATION GLOVES (6MIL), TESTED FOR USE WITH...
K101630 · LZA
Pt. Smartglove Indonesia
General Hospital · 89d
Cleared Sep 07, 2010
INFINIX-I INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V
K101868 · OWB
Toshiba America Medical Systems, In.C
Radiology · 67d
Cleared Sep 07, 2010
6F ENGAGE/ENGAGE TR INTRODUCER
K101883 · DYB
St Jude Medical
Cardiovascular · 63d
Cleared Sep 07, 2010
MERIT BIPOLAR COAGULATION PROBE
K102273 · KNS
Merit Medical Systems, Inc.
Gastroenterology & Urology · 27d
Cleared Sep 07, 2010
NON-ABLATIVE WRINKLE TREATMENT HANDPIECE
K102368 · GEI
Ellman Int'L, Inc.
General & Plastic Surgery · 18d
Cleared Sep 03, 2010
CLEARWAVE PHOTOTHERAPY SYSTEM FOR ACNE, MODEL: CWST2
K091125 · ONE
Verilux
General & Plastic Surgery · 504d
Cleared Sep 03, 2010
SUPERIOR STARBURST REUSABLE SELF-ADHERING TENS/NMES/FES STIMULATING ELECTRODE
K100418 · GXY
Covidien
Neurology · 199d
Cleared Sep 03, 2010
SPAPLUS ANALYZER
K100455 · DBI
The Binding Site
Immunology · 198d
Cleared Sep 03, 2010
AUDIT MICROCV AMMONIAN/ETHANOL LINEARITY SET, MODEL K712M-5
K100718 · JJY
Aalto Scientific, Ltd.
Chemistry · 175d
Cleared Sep 03, 2010
ROMIAPEX MODEL A-15
K101054 · LQY
Romidan, Ltd.
Dental · 141d