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

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176,076 results
57049–57072 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 26, 2008
PLICATOR GSX SUTURING SYSTEM, PLICATOR GSX, PLICATOR INSTRUMENT, PLICATOR GSX...
K073671 · OCW
Ndo Surgical, Inc.
Gastroenterology & Urology · 90d
Cleared Mar 26, 2008
MCT-DIABETES
K073699 · NBW
Mycare Team, Inc.
Chemistry · 86d
Cleared Mar 26, 2008
VARI-LASE ENDOVENOUS LASER CONSOLE, MODEL 7542
K080104 · GEX
Vascular Solutions, Inc.
General & Plastic Surgery · 72d
Cleared Mar 26, 2008
DISTAL HUMERAL PLATES WITH ANGULAR STABILITY
K080184 · HRS
I.T.S. Implantat-Technologie-Systeme...
Orthopedic · 61d
Cleared Mar 26, 2008
MTA ROOT CANAL SEALER
K080203 · KIF
Dentsply Interntional
Dental · 58d
Cleared Mar 26, 2008
MODIFICATION TO: FOX PLUS PTA CATHETER
K080264 · LIT
Abbott Vascular-Vascular Solutions
Cardiovascular · 54d
Cleared Mar 26, 2008
PECD-01 AND PECD QUICK-01
K080514 · ELW
3M Espe AG Dental Products
Dental · 30d
Cleared Mar 25, 2008
SMALL INTESTINAL VIDEOSCOPE SYSTEM
K071254 · FDA
Olympus Medical Systems Corporation
Gastroenterology & Urology · 326d
Cleared Mar 25, 2008
BIOFLEX
K072321 · NQP
Biospine Co., Ltd.
Orthopedic · 218d
Cleared Mar 25, 2008
SCOUTPRO 8F, 7F AND SLITTER TOOL ADVANCED
K072329 · DQY
Biotronik, Inc.
Cardiovascular · 218d
Cleared Mar 25, 2008
EZ SCAN PLUS BLOOD GLUCOSE MONITORING SYSTEM
K072441 · NBW
Tyson Bioresearch, Inc.
Chemistry · 208d
Cleared Mar 25, 2008
E-VAC
K073455 · GEI
New Leaf Medical, Inc.
General & Plastic Surgery · 106d
Cleared Mar 25, 2008
AAP CANNULATED SCREW AND DARCO HEADED SCREW
K080101 · HWC
Aap Implantate AG
Orthopedic · 71d
Cleared Mar 25, 2008
AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE (IHVLP)
K080170 · BTR
C.R. Bard, Inc.
Anesthesiology · 61d
Cleared Mar 25, 2008
CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET...
K080183 · DIF
Roche Diagnostics Corp.
Chemistry · 60d
Cleared Mar 24, 2008
DENTAL IMPLANT, DENTAL ABUTMENT, ABUTMENT SCREW, COVER SCREW, HEALING ABUTMENT
K070184 · DZE
Ospol AB
Dental · 430d
Cleared Mar 24, 2008
XPS 3000 SYSTEM
K073255 · ERL
Medtronic Xomed, Inc.
Ear, Nose, Throat · 126d
Cleared Mar 24, 2008
VERTEBRON VBR SYSTEM
K073502 · MQP
Vertebron, Inc.
Orthopedic · 102d
Cleared Mar 24, 2008
BONE FIXATION WIRE (KIRSCHNER WIRE)
K073674 · HTY
Signal Medical Corp.
Orthopedic · 87d
Cleared Mar 24, 2008
MODEL TW SB, SCALP VEIN SET
K073705 · FMI
Shandong Qiaopai Group Co., Ltd.
General Hospital · 84d
Cleared Mar 24, 2008
DASH 2500 PATIENT MONITOR
K080157 · MHX
Ge Medical Systems Information...
Cardiovascular · 61d
Cleared Mar 24, 2008
CAYMAN BUTTRESS PLATE SYSTEM
K080302 · KWQ
K2m, Inc.
Orthopedic · 48d
Cleared Mar 24, 2008
SURESIGNS VM SERIES PATIENT MONITOR, MODELS VM4, VM6, VM8, VM3 AND VS3
K080495 · MHX
Philips Medical Systems
Cardiovascular · 31d
Cleared Mar 24, 2008
MODELS TENS 7000, EMS 7500 AND TWIN STIM
K080661 · IPF
Koalaty Products, Inc.
Physical Medicine · 14d