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
39289–39312 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 09, 2014
ISO-GARD MASK
K132729 · CBN
Teleflexmedical, Inc.
Anesthesiology · 128d
Cleared Jan 09, 2014
FASTEP S10 HCG SERUM/URINE COMBO TEST
K132834 · JHI
Polymed Therapeutics, Inc.
Chemistry · 121d
Cleared Jan 09, 2014
TAMPAX M PLASTIC TAMPONS, UNSCENTED
K133244 · HEB
The Procter & Gamble Company
Obstetrics & Gynecology · 79d
Cleared Jan 09, 2014
ITOTAL CRUCIATE RETAINING, IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEMS, IDUO...
K133256 · JWH
Conformis, Inc.
Orthopedic · 78d
Cleared Jan 09, 2014
MEDOS HILITE 7000 & 7000 LT OXYGENATOR
K133261 · DTZ
Medos Medizintechnik AG
Cardiovascular · 78d
Cleared Jan 09, 2014
MIDLINE (TM)
K133286 · OVD
Centinel Spine, Inc.
Orthopedic · 76d
Cleared Jan 09, 2014
ALAMO C
K133321 · ODP
Alliance Partners, LLC
Orthopedic · 72d
Cleared Jan 09, 2014
RAMPART-L
K133371 · MAX
Spineology, Inc.
Orthopedic · 69d
Cleared Jan 09, 2014
HAMMERLOCK 2
K133520 · HTY
Biomedical Enterprises, Inc.
Orthopedic · 55d
Cleared Jan 08, 2014
ORTHODONTIC MINISCREW FOR ABSOLUTE ANCHORAGE
K130476 · OAT
Dental Morelli
Dental · 317d
Cleared Jan 08, 2014
ENDOVASCULAR LASER VENOUS SYSTEM KIT WITH 2 RING RADIAL EMITTING FIBER
K130681 · GEX
Biolitec Sia
General & Plastic Surgery · 301d
Cleared Jan 08, 2014
SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIRE
K130843 · DRC
Oscor, Inc.
Cardiovascular · 287d
Cleared Jan 08, 2014
V-PATCH SYSTEM
K131000 · DSI
Intelesens Limited
Cardiovascular · 273d
Cleared Jan 08, 2014
ULTRASONIC MESH NEBULIZER
K132247 · CAF
Foshan Gaunying Electronics Co., Ltd.
Anesthesiology · 173d
Cleared Jan 08, 2014
VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN)
K132843 · PEN
Nanosphere, Inc.
Microbiology · 120d
Cleared Jan 08, 2014
MEDCOMP POWER INJECTABLE SAFETY HUBER NEEDLE
K132880 · FPA
Medical Components, Inc.
General Hospital · 117d
Cleared Jan 08, 2014
3I T3(R) EXTERNAL HEX DENTAL IMPLANTS
K133049 · DZE
Biomet 3i
Dental · 103d
Cleared Jan 08, 2014
EMERGE MEDICAL SMALL FRAGMENT LOCKED PLATING SYSTEM
K133452 · HRS
Emerge Medical
Orthopedic · 57d
Cleared Jan 08, 2014
ENDOCHOICE WATER BOTTLE CAP IRRIGATION SYSTEM
K133747 · FEQ
Endochoice, Inc.
Gastroenterology & Urology · 30d
Cleared Jan 08, 2014
OCCLUDER OCCLUSION BALLOON CATHETER
K133750 · EYB
Boston Scientific Corporation
Gastroenterology & Urology · 30d
Cleared Jan 08, 2014
ENDO GIA(TM) EXTRA LONG ADAPTER
K133762 · GDW
Covidien, LLC
General & Plastic Surgery · 28d
Cleared Jan 07, 2014
MEDISISS REPROCESSED ULTRASONIC INSTRUMENTS
K124033 · NLQ
Surgical Instruments Service and...
General & Plastic Surgery · 375d
Cleared Jan 07, 2014
BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION...
K130122 · CFN
Beckman Coulter, Inc.
Immunology · 355d
Cleared Jan 07, 2014
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K131832 · LYZ
Shandong Binxiang Medical Products...
General Hospital · 201d