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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
37273–37296 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 20, 2014
ULTHERA SYSTEM
K134032 · OHV
Ulthera, Inc.
General & Plastic Surgery · 171d
Cleared Jun 20, 2014
VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP)
K140083 · PCH
Nanosphere, Inc.
Microbiology · 158d
Cleared Jun 20, 2014
SECURE-GARD SURGICAL AND PROCEDURE FACE MASK
K140155 · FXX
Cardinal Health200, LLC
General Hospital · 149d
Cleared Jun 20, 2014
SOMNODENT FUSION, CLASSIC
K140278 · LRK
Somnomed, Inc.
Dental · 137d
Cleared Jun 20, 2014
NITRILE POWDER FREE EXAMINATION GLOVE - AQUA BLUE (ABLU) / VIOLET BLUE (VBLU)...
K140610 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 102d
Cleared Jun 20, 2014
SUREFLEX LITHOTRIPSY LASER FIBERS
K140679 · GEX
American Medical Systems
General & Plastic Surgery · 94d
Cleared Jun 20, 2014
COMFORTEAR LACRISOLVE ABSORBABLE PUNCTUM PLUG, LACRISOLVE ABSORBABLE PUNCTUM...
K140711 · LZU
Paragon Bioteck, Inc.
Ophthalmic · 91d
Cleared Jun 20, 2014
AXSOS 3 TI LOCKING PLATE SYSTEM
K141121 · HRS
Stryker Trauma AG
Orthopedic · 51d
Cleared Jun 20, 2014
VITEK 2 AST GP CEFTAROLINE
K141149 · LON
bioMerieux, Inc.
Microbiology · 46d
Cleared Jun 20, 2014
QUENTRY DOSE REVIEW
K141199 · LLZ
Brainlab AG
Radiology · 42d
Cleared Jun 20, 2014
VARIAX 2 ONE THIRD TUBULAR PLATING SYSTEM
K141204 · HRS
Stryker Trauma AG
Orthopedic · 42d
Cleared Jun 20, 2014
RADSPA
K141329 · LLZ
Telerad Tech Private Limited
Radiology · 30d
Cleared Jun 20, 2014
ECHO TIP ULTRA FIDUCIAL NEEDLE
K141356 · NEU
Wilson-Cook Medical, Inc.
General & Plastic Surgery · 28d
Cleared Jun 19, 2014
JR IMPLANT SYSTEM
K130694 · DZE
LK Consulting Group USA, Inc.
Dental · 462d
Cleared Jun 19, 2014
SILDENT
K132869 · ELW
Hrs Co., Ltd.
Dental · 279d
Cleared Jun 19, 2014
HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVER
K132891 · FRO
The Hymed Group Corp.
General & Plastic Surgery · 276d
Cleared Jun 19, 2014
ABBVIE PEG
K133087 · KNT
AbbVie, Inc.
Gastroenterology & Urology · 262d
Cleared Jun 19, 2014
ABBVIE NJ
K133129 · KNT
AbbVie, Inc.
Gastroenterology & Urology · 262d
Cleared Jun 19, 2014
TRUFREEZE SYSTEM
K133258 · GEH
CSA Medical, Inc.
General & Plastic Surgery · 239d
Cleared Jun 19, 2014
DISPOSABLE PRESSURE MANOMETER
K140370 · CAP
Besmed Health Business Corp
Anesthesiology · 125d
Cleared Jun 19, 2014
MIROMATRIX WOUND MATRIX
K140510 · KGN
Miromatrix Medical, Inc.
General & Plastic Surgery · 111d
Cleared Jun 19, 2014
PROCEM
K140644 · NEA
Ototronix, LLC
Ear, Nose, Throat · 98d
Cleared Jun 19, 2014
COSMOLOCK PEDICLE SCREW SYSTEM
K140678 · MNH
Kalitec Direct, LLC
Orthopedic · 93d
Cleared Jun 19, 2014
OSSEOFLEX SB
K140937 · NDN
Osseon, LLC
Orthopedic · 69d