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
74929–74952 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 29, 2002
RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM
K021194 · DCK
Hemagen Diagnostics, Inc.
Chemistry · 105d
Cleared Jul 29, 2002
RESORBABLE CRANIAL CLAMPS
K021408 · GXR
Synthes (Usa)
Neurology · 87d
Cleared Jul 29, 2002
HERPESELECT 1 ELISA IGG, MODEL EL0910G
K021429 · MXJ
Focus Technologies, Inc.
Microbiology · 87d
Cleared Jul 29, 2002
MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020
K021604 · HBL
Ohio Medical Instrument Co., Inc.
Neurology · 74d
Cleared Jul 29, 2002
CODMAN BACTISEAL EVD CATHETER SET
K021653 · JXG
Codman & Shurtleff, Inc.
Neurology · 70d
Cleared Jul 29, 2002
CRPEX-BR C-REACTIVE PROTEIN LIT ASSAY, CRPEX-BR CRP CALIBRATOR SET
K021757 · DCN
Good Biotech Corp.
Immunology · 61d
Cleared Jul 29, 2002
ADVANTAGE SIM 6.0
K021780 · KPQ
General Electric Medical Systems
Radiology · 60d
Cleared Jul 29, 2002
ADMIRA SEAL
K021842 · EBC
Voco GmbH
Dental · 54d
Cleared Jul 29, 2002
ENDIUS TITLE SPINAL FIXATION SYSTEM
K021881 · MNH
Endius, Inc.
Orthopedic · 52d
Cleared Jul 29, 2002
PSG INPUT BOX, MODEL JE-912AK
K022121 · OLV
Nihon Kohden America, Inc.
Neurology · 28d
Cleared Jul 29, 2002
BD VACUTAINER PLUS PST II TUBE
K022130 · JKA
Becton, Dickinson & CO
Chemistry · 28d
Cleared Jul 29, 2002
MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632
K022161 · GKZ
Beckman Coulter, Inc.
Hematology · 26d
Cleared Jul 29, 2002
MODIFICATION TO CARDEON AEGIS CATHETER
K022174 · DWF
Cardeon Corp.
Cardiovascular · 26d
Cleared Jul 29, 2002
PENTRA 120/PENTRA 120 RETIC OPTIONS SPS, MODEL PENTRA 120
K022200 · GKZ
Abx Diagnostics
Hematology · 24d
Cleared Jul 26, 2002
ECCOVISION ACOUSTIC DIAGNOSTIC IMAGING ACOUSTIC PHARYNGOMETER
K011329 · BXQ
E. Benson Hood Lab, Inc.
Anesthesiology · 451d
Cleared Jul 26, 2002
SHARPOINT ULTRAPLUG EXTENDED WEAR PLUG
K020882 · LZU
Surgical Specialties Corp
Ophthalmic · 130d
Cleared Jul 26, 2002
FOSSA URETERAL STONE SWEEPER
K021602 · FAD
Fossa Industries, Inc.
Gastroenterology & Urology · 72d
Cleared Jul 26, 2002
ILT ADVANCING MECHANISM, MODEL A115AMI
K021638 · DQX
Intra Luminal Therapeutics, Inc.
Cardiovascular · 67d
Cleared Jul 26, 2002
XTD THROMBECTOMY CATHETER, XX CM
K021641 · QEW
Xtrak Medical, Inc.
Cardiovascular · 67d
Cleared Jul 26, 2002
CHROLOY SOLDER
K021965 · EJH
Neirynck & Vogt NV
Dental · 39d
Cleared Jul 26, 2002
CERALOY SOLDER
K021968 · EJH
Neirynck & Vogt NV
Dental · 39d
Cleared Jul 26, 2002
ELPH INJECTION SYSTEM
K022116 · DXT
Mallinckrodt Inc., Liebel-Flarsheim...
Cardiovascular · 25d
Cleared Jul 26, 2002
ZETA DIAGNOSTIC RETINAL IMAGING SYSTEM
K022164 · HKI
Zeta Development Laboratories
Ophthalmic · 23d
Cleared Jul 25, 2002
WU'S 3-WHEELED NEO SCOOTER, WT-M3
K014119 · INI
Wu'S Tech Co., Ltd.
Physical Medicine · 220d