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
52345–52368 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 09, 2009
MODIFICATION TO: CONFORMIS IUNI UNICONDYLAR KNEE REPAIR SYSTEM
K092441 · HSX
Conformis, Inc.
Orthopedic · 30d
Cleared Sep 08, 2009
DOCTOR SMILE A-810 AND B-980 LASERS
K091562 · GEX
Lambda Scientific Spa
General & Plastic Surgery · 103d
Cleared Sep 08, 2009
ANGLEFIX T LOCKING PLATE, MODELS AF-001 (PLATE), ST-1 (LOCKING SCREW)
K091619 · KTT
Anglefix
Orthopedic · 97d
Cleared Sep 08, 2009
CODMAN ANEURYSM CLIPS, CODMAN AVM MICRO CLIP SYSTEM, CODMAN SLIM-LINE GRAFT,...
K091921 · HCH
Codman & Shurtleff, Inc.
Neurology · 70d
Cleared Sep 05, 2009
FDI GLUCOSE CONTROL LEVELS 1, 2 AND 3
K092645 · JJX
Fujirebio Diagnostics,Inc.
Chemistry · 9d
Cleared Sep 04, 2009
YUYUE OXYGENMAX OXYGEN CONCENTRATOR, MODELS: 7F-5A/7F-5B
K083559 · CAW
Jiangsu Yuyue Medical Equipment&...
Anesthesiology · 276d
Cleared Sep 04, 2009
SILVER IMPREGNATED HYDROFIBER DRESSING REINFORCED WITH NYLON (FLAT)
K090254 · FRO
Convatec, A Division of E.R. Squibb &...
General & Plastic Surgery · 214d
Cleared Sep 04, 2009
CERAMENT IBONE VOID FILLER HIGH CONTRAST, MODEL A 0210-12
K090871 · MQV
Bonesupport AB
Orthopedic · 158d
Cleared Sep 04, 2009
CORONARY SINUS DEFLECTABLE MAPPING CATHETER, MODEL D-1263-01, WEBSTER CS...
K090898 · DRF
Biosense Webster, Inc.
Cardiovascular · 156d
Cleared Sep 04, 2009
EES SINGLE SITE LAPAROSCOPIC SEAL CAP ASSEMBLY W/ACCESSORIES, MODEL SSL3P,...
K091211 · GCJ
Ethicon Endo-Sugery, LLC
General & Plastic Surgery · 130d
Cleared Sep 04, 2009
ATLAS SPINE SPACER
K091406 · MQP
Atlas Spine, LLC
Orthopedic · 115d
Cleared Sep 04, 2009
TRULY AUTOMATIC WRIST BLOOD PRESSURE MONITOR, MODEL DW100,DW200,...
K091415 · DXN
Truly Instrument Co., Ltd.
Cardiovascular · 114d
Cleared Sep 04, 2009
TRULY AUTOMATIC ARM BLOOD PRESSURE...
K091434 · DXN
Truly Instrument Co., Ltd.
Cardiovascular · 114d
Cleared Sep 04, 2009
CLEARVIEW ADVANCED STREP A , MODEL 737-430
K091489 · GTY
Binax, Inc.
Microbiology · 107d
Cleared Sep 04, 2009
UCP HOME DRUG SCREENING TESTS
K091588 · DKZ
Ucp Biosciences, Inc.
Chemistry · 94d
Cleared Sep 04, 2009
NITRILE POWDER FRE EXAMINATION GLOVES (BLUE) TESTED FOR USE WITH CHEMOTHREAPY...
K091652 · LZA
Hartalega Sdn Bhd
General Hospital · 87d
Cleared Sep 04, 2009
EASY RA D BIL REAGENT MODEL 10212, EASY RA GLU-H REAGENT MODEL 10200
K091991 · CIG
Medica Corp.
Chemistry · 64d
Cleared Sep 04, 2009
INREACH SYSTEM, MODEL AAS00161-02
K092365 · JAK
Superdimension, Ltd.
Radiology · 30d
Cleared Sep 04, 2009
MODIFICATION TO SI JOINT FUSION SYSTEM
K092375 · OUR
SI-BONE, Inc.
Orthopedic · 30d
Cleared Sep 04, 2009
SPECTRANETICS QUICK CROSS EXTREME SUPPORT CATHETERS
K092396 · DQY
Spectranetics Corp.
Cardiovascular · 30d
Cleared Sep 04, 2009
INVIROSNAP 50 AND 100 UNIT INSULIN SAFETY SYRINGES
K092413 · MEG
Inviro Medical Devices, Inc.
General Hospital · 28d
Cleared Sep 04, 2009
1 ML FIXED NEEDLE, 3 ML LUER LOCK, 5 ML LUER LOCK, 10 ML LUER LOCK, 20 ML...
K092430 · MEG
Inviro Medical Devices, Inc.
General Hospital · 28d
Cleared Sep 04, 2009
MODIFICATION TO: POLARCATH PERIPHERAL DILATATION SYSTEM
K092455 · LIT
Boston Scientific Corporation
Cardiovascular · 25d
Cleared Sep 04, 2009
CLO-SURPLUS P.A.D.
K092552 · QSY
Scion Cardio-Vascular, Inc.
General & Plastic Surgery · 15d