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
68665–68688 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 13, 2004
BAWMED RESCUE MASK
K031431 · CBP
Bawmed UK
Anesthesiology · 434d
Cleared Jul 13, 2004
CAPTIA HSV 1 IGG TYPE SPECIFIC ELISA KIT
K033105 · MXJ
Trinity Biotech USA
Microbiology · 287d
Cleared Jul 13, 2004
CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KIT
K033106 · MYF
Trinity Biotech USA
Microbiology · 287d
Cleared Jul 13, 2004
INTELIPORT OCCLUDING DEVICE
K040231 · LZU
Alcon, Inc.
Ophthalmic · 162d
Cleared Jul 13, 2004
CRANEX BASEX D OR CRANEX EXCEL D
K040382 · EHD
Soredex Palodex Group OY
Radiology · 147d
Cleared Jul 13, 2004
N-VIVO CALCIUM SCORE ON IA CHASSIS RELEASE, MODEL RELEASE X.XX
K040782 · JAK
Image Analysis, Inc.
Radiology · 109d
Cleared Jul 13, 2004
ACCU-STAT HOME DRUG TEST CUP FOR MAIJUANNA (THC), COCAINE (COC), AMPHETAMINE...
K041221 · LDJ
Accu-Stat Diagnostics, Inc.
Toxicology · 64d
Cleared Jul 13, 2004
PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT_WITH SERIAL DILATORS...
K041348 · JOH
Smiths Medical
Anesthesiology · 54d
Cleared Jul 13, 2004
5M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR ME511L (MDL2105A)
K041737 · LLZ
Totoku Electric Co., Ltd.
Radiology · 15d
Cleared Jul 13, 2004
RAPIDIACOLON
K041761 · LLZ
Infinitt Co., Ltd.
Radiology · 13d
Cleared Jul 13, 2004
SHIMADZU MOBILE X-RAY SYSTEM MUX-100D SERIES
K041763 · IZL
Shimadzu Corp.
Radiology · 13d
Cleared Jul 12, 2004
ELECTRO-OPTICAL AIR STERILIZER WITH IONIZER
K033448 · FRA
John Mfg., Ltd.
General Hospital · 257d
Cleared Jul 12, 2004
PHYSICIAN INDUSTRIES' DURAMETER SYRINGE
K033739 · FMF
Physician Industries, Inc.
General Hospital · 227d
Cleared Jul 12, 2004
TEMPORARY BIPOLAR MYOCARDIAL PACING WIRE
K033858 · LDF
European Custom Manufacturing BV
Cardiovascular · 214d
Cleared Jul 12, 2004
DIAPHARMA FACTOR X KIT
K040362 · GJT
Diapharma Group, Inc.
Hematology · 150d
Cleared Jul 12, 2004
SHARPSAWAY II LOCKING DISPOSABLE CUP
K041153 · FMI
Arrow Intl., Inc.
General Hospital · 70d
Cleared Jul 12, 2004
XPS 3000 SYSTEM
K041413 · ERL
Medtronic Xomed, Inc.
Ear, Nose, Throat · 46d
Cleared Jul 12, 2004
CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020
K041574 · DTD
Guidant Corporation
Cardiovascular · 28d
Cleared Jul 09, 2004
CORE NEEDLE BIOPSY
K040266 · KNW
Remington Medical, Inc.
Gastroenterology & Urology · 155d
Cleared Jul 09, 2004
LPS METAPHYSEAL SLEEVE (LIMB PRESERVATION SYSTEM)
K040281 · JWH
DePuy Orthopaedics, Inc.
Orthopedic · 154d
Cleared Jul 09, 2004
TAMPAX TAMPONS (JUNIOR, REGULAR, SUPER AND SUPER PLUS ABSORBENCIES)
K040999 · HEB
Procter & Gamble Co.
Obstetrics & Gynecology · 81d
Cleared Jul 09, 2004
BIOPORE BALLOON DILATION CATHETER
K041293 · LIT
Bipore, Inc.
Cardiovascular · 56d
Cleared Jul 09, 2004
VEROSCOPE OPTICAL VERESS CANNULA & DILATION TUBE SYSTEM
K041321 · HET
Richard Wolf Medical Instruments Corp.
Obstetrics & Gynecology · 52d
Cleared Jul 09, 2004
FREEFORM BLUE POWDER-FREE NITRILE EXAMINATION GLOVES
K041391 · LZA
Hartalega Sdn Bhd
General Hospital · 45d