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
59257–59280 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 29, 2007
GORE BALLOON SHEATH
K070770 · MJN
W.L. Gore & Associates, Inc.
Cardiovascular · 101d
Cleared Jun 29, 2007
EVERLIFE INTERFERENTIAL CURRENT THERAPY, MODEL IF-100507
K070890 · LIH
Everlife Medical Equipment Co., Ltd.
Neurology · 91d
Cleared Jun 29, 2007
BIONEXIA HCG PREGNANCY CASSETTE AND DIPSTICK TESTS, MODEL 08-HCG AND 02-HCG
K070921 · JHI
Applied Dna Technologies, Inc.
Chemistry · 88d
Cleared Jun 29, 2007
MODIFICATION TO: RAINBOW ADHESIVE CO-OXIMETRY SENSORS
K071024 · DQA
Masimo Corporation
Anesthesiology · 79d
Cleared Jun 29, 2007
BIONEXIA HCG PREGNANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS, MODELS...
K071030 · JHI
Applied Dna Technologies, Inc.
Chemistry · 79d
Cleared Jun 29, 2007
GAME READY PROFESSIONAL THERAPY SYSTEM, MODEL 550100, GAME READY...
K071050 · IRP
Coolsystems, Inc.
Physical Medicine · 77d
Cleared Jun 29, 2007
RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD
K071053 · KXA
Biomet, Inc.
Orthopedic · 77d
Cleared Jun 29, 2007
MULTIPLE PATIENT RECEIVER, MODEL ORG-9700A
K071058 · DRG
Nihon Kohden America, Inc.
Cardiovascular · 74d
Cleared Jun 29, 2007
SPYCATCH STONE RETRIEVAL BASKET
K071066 · LQR
Boston Scientific Corp
Gastroenterology & Urology · 74d
Cleared Jun 29, 2007
TRABECULAR METAL GLENOID- B/F COMPLETE SHOULDER SOLUTION
K071090 · KWS
Zimmer Trabecular Metal Technology
Orthopedic · 72d
Cleared Jun 29, 2007
ARTHREX BIO- COMPOSITE SUTURE ANCHORS: BIO-COMPOSITE PUSHLOCK, BIO-COMPOSITE...
K071177 · HWC
Arthrex, Inc.
Orthopedic · 63d
Cleared Jun 29, 2007
8FR TURBO BOOSTER, GUIDE CATHETER, 7FR TURBO BOOSTER, MODEL 518-063, 518-043
K071226 · PDU
Spectranetics Corp.
Cardiovascular · 57d
Cleared Jun 29, 2007
ACUNAV DIAGNOSTIC ULTRASOUND CATHETER 8F AND 10F
K071234 · OBJ
Siemens Medical Solutions USA, Inc.
Cardiovascular · 57d
Cleared Jun 29, 2007
MINI QUICKANCHOR AND QUICKANCHOR PLUS WITH ORTHOCORD
K071257 · JDR
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 56d
Cleared Jun 29, 2007
EMBRACE DUAL CURE COMPOSITE MATERIALS
K071278 · EBF
Pulpdent Corporation
Dental · 53d
Cleared Jun 29, 2007
CERADRILL
K071352 · EJL
Gebr. Brasseler GmbH & Co. KG
Dental · 45d
Cleared Jun 29, 2007
MODIFICATION TO:SBI RINGFIX
K071394 · KTT
Small Bone Innovations, Inc.
Orthopedic · 39d
Cleared Jun 29, 2007
REALHAND HIGH DEXTERITY (HD) INSTRUMENTS
K071488 · GCJ
Novare Surgical Systems, Inc.
General & Plastic Surgery · 30d
Cleared Jun 29, 2007
EXPEDIUM 4.5MM SPINE SYSTEM
K071495 · NKB
Depuy Spine, A Johnson & Johnson Company
Orthopedic · 29d
Cleared Jun 29, 2007
ATLAS SPINE VERTEBRAL BODY REPLACEMENT
K071497 · MQP
Atlas Spine, Inc.
Orthopedic · 29d
Cleared Jun 29, 2007
HALO360' COAGULATION CATHETER
K071543 · GEI
Barrx Medical, Incorporated
General & Plastic Surgery · 24d
Cleared Jun 28, 2007
EUROIMMUN ANTI-HSV-2 ELISA (IGG) AND ANTI-HSV-1 ELISA (IGG) KIT
K061239 · MYF
Euroimmun Us, LLC
Microbiology · 421d
Cleared Jun 28, 2007
SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TEST
K061496 · MJH
Sa Scientific , Ltd.
Microbiology · 393d
Cleared Jun 28, 2007
OSSIPRO BONE SUBSTITUTE MATERIAL
K062630 · MQV
Etex Corp.
Orthopedic · 296d