FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
73129–73152 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 24, 2003
SYNTEX POWDER-FREE LATEX EXAMINATION GLOVE-BLUE COLOR
K023826 · LYY
Syntex Healthcare Products Co., Ltd.
General Hospital · 67d
Cleared Jan 24, 2003
UCP DENTAL MATERIAL
K023831 · EJT
Precious Chemicals U.S.A., Inc.
Dental · 67d
Cleared Jan 24, 2003
POWDER FREE POLYMER COATED (ACRYLIC BASED) PATIENT EXAMINIATION GLOVES
K023866 · LYY
Kl-Kepong Rubber Products Sdn. Bhd.
General Hospital · 65d
Cleared Jan 24, 2003
GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM
K023878 · NFA
Medtronic Vascular
Cardiovascular · 64d
Cleared Jan 24, 2003
QUANTITATIVE VASCULAR ANGIOGRAPHY - CMS
K023970 · IZI
Medis Medical Imaging Systems BV
Radiology · 56d
Cleared Jan 24, 2003
PRE-POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM
K023977 · LYY
Starmatrix Sdn Bhd
General Hospital · 53d
Cleared Jan 24, 2003
NITRILE EXAMINATION GLOVES, POWDER FREE
K023978 · LZA
Starmatrix Sdn Bhd
General Hospital · 53d
Cleared Jan 24, 2003
NITRILE EXAMINATION GLOVES, PRE-POWDERED
K023979 · LZA
Starmatrix Sdn Bhd
General Hospital · 53d
Cleared Jan 24, 2003
NITREX NITINOL GUIDEWIRE
K024021 · DQX
Ev3 Corporation
Cardiovascular · 50d
Cleared Jan 24, 2003
SHARP VIEW IMAGE ENHANCEMENT SYSTEM
K024028 · LLZ
Context Vision AB
Radiology · 49d
Cleared Jan 24, 2003
IVUS PLUS
K024103 · LLZ
Indec Systems, Inc.
Radiology · 43d
Cleared Jan 24, 2003
MODIFICATION TO HI-TORQUE WHISPER GUIDEWIRE
K030019 · DQX
Guidant Corp.
Cardiovascular · 21d
Cleared Jan 24, 2003
BURBANK TENACULUM, MODEL 09-0011-01
K030078 · HDC
Vascular Control Systems, Inc.
Obstetrics & Gynecology · 15d
Cleared Jan 24, 2003
H2 HEATED HUMIDIFIER
K030090 · BTT
Respironics, Inc.
Anesthesiology · 14d
Cleared Jan 24, 2003
ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3
K030102 · JJT
Bayer Healthcare, LLC
Chemistry · 14d
Cleared Jan 24, 2003
MEDISISS PHACOEMULSIFICATION TIPS/NEEDLES
K030179 · NKX
Surgical Instruments Service and...
Ophthalmic · 7d
Cleared Jan 23, 2003
INTERPORE CROSS INTERNATIONAL ANTERIOR FIXATION DEVICE (AFD)
K022143 · MQP
Interpore Cross Intl.
Orthopedic · 205d
Cleared Jan 23, 2003
BARD ER URETERAL STENT WITH SUTURE
K022447 · FAD
C.R. Bard, Inc.
Gastroenterology & Urology · 181d
Cleared Jan 23, 2003
DRX3000
K022602 · ITH
Axiom Usa., Inc.
Physical Medicine · 170d
Cleared Jan 23, 2003
LUMEND FRONTRUNNER CTO CATHETER
K023114 · PDU
Lumend, Inc.
Cardiovascular · 126d
Cleared Jan 23, 2003
AX200 AUTOMATIC X-RAY FILM PROCESSOR, MODEL 6586.036
K023613 · IXW
Alphatek Corp.
Radiology · 87d
Cleared Jan 23, 2003
DIMISIL SCAR GEL
K023678 · MDA
Aesthetic and Reconstructive...
General & Plastic Surgery · 83d
Cleared Jan 23, 2003
SMITH & NEPHEW GLOBAL BIPOLAR SYSTEM
K023743 · KWY
Smith & Nephew, Inc.
Orthopedic · 77d
Cleared Jan 23, 2003
XENO III DENTAL ADHESIVE
K023776 · KLE
Dentsply Intl.
Dental · 72d