FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
74905–74928 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 11, 2002
TOTAL HIP FEMORAL HEAD - 12/14 TAPER
K021673 · LZO
Smith & Nephew, Inc.
Orthopedic · 21d
Cleared Jun 10, 2002
SURGISIS GUIDED TISSUE REGENERATION MATRIX
K010952 · NPL
Cook Biotech, Inc.
Dental · 437d
Cleared Jun 10, 2002
LIFESIGN THC, STATUS STIK THC, ACCUSIGN STIK THC, LIFESIGN MARIJUANA,...
K014066 · LDJ
Princeton BioMeditech Corp.
Toxicology · 182d
Cleared Jun 10, 2002
LIFESIGN COCAINE, MARIJUANA (THC), LIFESIGN DOA2 (THC/COC), STATUS STIK...
K014067 · DIO
Princeton BioMeditech Corp.
Toxicology · 182d
Cleared Jun 10, 2002
LIFESIGN COC, STATUS STIK COC, ACCUSIGN STIK COC, ACCUSTIK COC
K014069 · DIO
Princeton BioMeditech Corp.
Toxicology · 182d
Cleared Jun 10, 2002
STAT PROFILE CRITICAL CARE XPRESS ANALYZER
K020297 · CHL
Nova Biomedical Corp.
Chemistry · 133d
Cleared Jun 10, 2002
OPTAX SYSTEM
K020800 · LQD
Optax Systems, Inc.
Neurology · 90d
Cleared Jun 10, 2002
CEFAR MEDICAL AB CEFAR PRIMO
K020803 · GZJ
Cefar Medical AB
Neurology · 90d
Cleared Jun 10, 2002
MARKNEW PRODUCTS ACUPUNCTURE NEEDLES
K020880 · MQX
Marknew Products
General Hospital · 84d
Cleared Jun 10, 2002
STARTOX DRUG OF ABUSE SCREENING TEST
K021006 · DKZ
Starplex Scientific, Inc.
Toxicology · 74d
Cleared Jun 10, 2002
TERUMO GAS FILTER
K021020 · CAH
Terumo Cardiovascular Systems Corp.
General Hospital · 73d
Cleared Jun 10, 2002
MODIFICATION TO N/T RHEUMATOLOGY CONTROLS SL 1 & 2
K021381 · JJY
Dade Behring, Inc.
Immunology · 40d
Cleared Jun 10, 2002
CASHMERE NON-STERILE, POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES...
K021388 · LYY
Seal Polymer Industries Bhd.
General Hospital · 39d
Cleared Jun 10, 2002
DERMAGRIP AND MULTIPLE POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE WITH...
K021536 · LYY
Wrp Specialty Products Sdn. Bhd.
General Hospital · 31d
Cleared Jun 10, 2002
ELASTYLITE SYNTHETIC POWDERED SURGICAL GLOVE
K021598 · KGO
Eci Medical Technologies, Inc.
General Hospital · 26d
Cleared Jun 10, 2002
(MULTIPLE LABELS) POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: YELLOW
K021743 · LZA
Copioumed Intl., Inc.
General Hospital · 13d
Cleared Jun 10, 2002
MODIFICATION TO BLUE SKY DENTAL IMPLANT SYSTEM
K021833 · DZE
Blue Sky Bio
Dental · 6d
Cleared Jun 10, 2002
SYNTHES (USA) 1.3 MM CRANIOFACIAL SCREWS
K021850 · DZL
Synthes (Usa)
Dental · 5d
Cleared Jun 07, 2002
INSIGHT, MODEL S980000
K012232 · FFX
Sandhill Scientific, Inc.
Gastroenterology & Urology · 326d
Cleared Jun 07, 2002
DUPLOREACH
K014088 · FMF
Baxter Healthcare Corp
General Hospital · 177d
Cleared Jun 07, 2002
TELESIS DIGITAL INFRARED THERMAL IMAGE SYSTEM, SPECTRUM 9000MB
K020783 · LHQ
Telesis Technologies, Inc.
Radiology · 88d
Cleared Jun 07, 2002
VERAVIEWEPOCS PANORAMIC X-RAY UNIT WITH CEPHALOMETRIC CAPABILITY
K021372 · EAG
J. Morita USA, Inc.
Radiology · 38d
Cleared Jun 07, 2002
PORTABLE HDX INTRAORAL X-RAY
K021378 · EHD
Dentalez Group
Radiology · 37d
Cleared Jun 07, 2002
LATEX EXAMINATION GLOVES, POWDER FREE, POLYMER COATED
K021412 · LYY
Arista Latindo Industrial Ltd. P.T
General Hospital · 35d