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

Filters: Cleared only ×
176,076 results
59713–59736 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 02, 2007
DDRCOMPACT, DDRCOMPACT PLUS AND DDRCOMPACT CHEST
K070678 · KPR
Swissray International, Inc.
Radiology · 51d
Cleared May 02, 2007
IMPLANT LOCATION SOFTWARE-T
K070713 · LLZ
Tactile Technologies, Ltd.
Radiology · 49d
Cleared May 02, 2007
NIO COLOR 3MP AND MDNC 3120
K070726 · LLZ
Barcoview, Medical Imaging Systems
Radiology · 48d
Cleared May 02, 2007
247 BP DEVICE
K070750 · DXN
Suntech Medical, Inc.
Cardiovascular · 44d
Cleared May 02, 2007
SYNTHES ADOLESCENT LATERAL ENTRY FEMORAL NAIL SYSTEM
K070843 · HSB
Synthes (Usa)
Orthopedic · 36d
Cleared May 02, 2007
MODIFICATION TO: BIOKNOTLESS BR ANCHOR / LUPINE BR ANCHOR
K070925 · MAI
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 29d
Cleared May 02, 2007
CTS-7700 DIGITAL ULTRASOUND IMAGING SYSTEM
K070982 · IYO
Shantou Institute of Ultrasonic...
Radiology · 26d
Cleared May 02, 2007
IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN, MODELS L5KCRP (200 TESTS),...
K071017 · NQD
Siemens Medical Solutions Diagnostics
Chemistry · 22d
Cleared May 01, 2007
ULTRASONIC SCALER, VARIOS 560
K062731 · ELC
Nakanishi, Inc.
Dental · 230d
Cleared May 01, 2007
PHARMASMART PUBLIC USE BLOOD PRESSURE MONITOR, MODELS PS-1000/PS-1500/PS-2000
K063137 · DXN
Pharmasmart, Inc.
Cardiovascular · 197d
Cleared May 01, 2007
EPI-C PLUS
K070494 · GEX
Espansione Marketing S.P.A
General & Plastic Surgery · 70d
Cleared May 01, 2007
OPTIMUM GP (ROFLUFOCON A,B,C,D&E) DAILY WEAR CONTACT LENS.
K070628 · HQD
Contamac, Ltd.
Ophthalmic · 55d
Cleared May 01, 2007
FLUOROPERM 92, 60, 30 AND 151 AND PARAGON HDS, HDS 100 AND THIN RIGID GAS...
K070637 · HQD
Paragon Vision Sciences
Ophthalmic · 55d
Cleared May 01, 2007
KSEA MINIATURE ENDOSCOPE, MODEL 11565
K070752 · EOB
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 43d
Cleared May 01, 2007
CRYOSPRAY ABLATION SYSTEM, MODEL CU 8407020500
K070893 · GEH
CSA Medical, Inc.
General & Plastic Surgery · 32d
Cleared May 01, 2007
MODIFICATION TO: ENSITE SYSTEM, MODEL, EE3000
K070902 · DQK
St Jude Medical
Cardiovascular · 29d
Cleared May 01, 2007
MODIFICATON TO: ZIMMER PERIARTICULAR LOCKING PLATES AND SCREWS
K070906 · HWC
Zimmer, Inc.
Orthopedic · 29d
Cleared May 01, 2007
VIEWMATE SYSTEM
K071028 · ITN
Ep Medsystems
Radiology · 20d
Cleared May 01, 2007
CONTACT LENS CASE
K071081 · LRX
Ningbo Kaida Rubber and Plastic...
Ophthalmic · 14d
Cleared Apr 30, 2007
GLOBUS PREMIUM MUSCLE STIMULATOR
K061632 · NGX
Domino S.R.L.
Physical Medicine · 322d
Cleared Apr 30, 2007
MESODERM
K061849 · EGJ
Aa Advanced Technology, Inc.
Physical Medicine · 304d
Cleared Apr 30, 2007
EASY CHECK BLOOD GLUCOSE MONITORING SYSTEM
K062538 · NBW
Diacare Corp.
Chemistry · 244d
Cleared Apr 30, 2007
BODY-STIM, BIOMODULATOR, BEST-RSI, BEST PRO, MODEL BEST-AV1
K062641 · GZJ
Avazzia, Inc.
Neurology · 236d
Cleared Apr 30, 2007
DELTACUT (APPARATUS AND CANNULA)
K063233 · KNW
PAJUNK GmbH Medizintechnologie
Gastroenterology & Urology · 187d