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
69289–69312 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 07, 2004
SYNTHES (USA) 2.4 MM LCP WRIST PLATE
K040588 · HRS
Synthes (Usa)
Orthopedic · 63d
Cleared May 07, 2004
GENEX BONE GRAFT SUBSTITUTE
K040600 · MQV
Biocomposites, Ltd.
Orthopedic · 60d
Cleared May 07, 2004
RICH-MAR AUTOPRISM INFRARED LAMP
K040679 · ILY
Rich-Mar Corp.
Physical Medicine · 53d
Cleared May 07, 2004
MEDLINE STRIDER MINI 3
K040818 · INI
Medline Industries, Inc.
Physical Medicine · 38d
Cleared May 07, 2004
MEDLINE STRIDER MINI 4
K040838 · INI
Medline Industries, Inc.
Physical Medicine · 37d
Cleared May 07, 2004
VIADUCT MINISCOPE AND ACCESSORIES
K040949 · GCT
Acueity, Inc.
Gastroenterology & Urology · 25d
Cleared May 07, 2004
USW NEEDLEKNIFE PAPILLOTOME
K040981 · KNS
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 22d
Cleared May 07, 2004
NOVA GLUCOSE LOW/HIGH LEVEL CONTROL SOLUTIONS
K041016 · JJX
Nova Biomedical Corp.
Chemistry · 17d
Cleared May 07, 2004
E-Z LUBRICATING JELLY
K041060 · KMJ
Chester Labs, Inc.
General Hospital · 14d
Cleared May 07, 2004
PANALOK RC LOOP ANCHOR
K041065 · JDR
Depuy Mitek
Orthopedic · 14d
Cleared May 06, 2004
DEPUY PINNACLE ACETABULAR CUP SYSTEM, ESL MARATHON POLYETHYLENE LINERS, AND...
K033273 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 209d
Cleared May 06, 2004
NVISION DATA MANAGEMENT SOFTWARE
K033307 · DQA
Nonin Medical, Inc.
Anesthesiology · 205d
Cleared May 06, 2004
OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM
K040225 · KWZ
Osteoimplant Technology, Inc.
Orthopedic · 94d
Cleared May 06, 2004
MODIFICATION TO CYCLONE ANTERIOR CERVICAL PLATE SYSTEM
K040397 · KWQ
Encore Medical, L.P.
Orthopedic · 79d
Cleared May 06, 2004
INTRA-AORTIC BALLOON (IAB)
K040801 · DSP
Arrow Intl., Inc.
Cardiovascular · 38d
Cleared May 06, 2004
EASY CORE BIOPSY SYSTEM
K040893 · FCG
Boston Scientific Corp
Gastroenterology & Urology · 30d
Cleared May 06, 2004
D731 MICRO 20 AND D733 MICRO 40 PEDIATRIC ARTERIAL FILTERS
K041061 · DTM
Dideco S.P.A.
Cardiovascular · 13d
Cleared May 06, 2004
NUMED MULLINS X PTA CATHETER
K041093 · DQY
NuMED, Inc.
Cardiovascular · 9d
Cleared May 06, 2004
MODIFICATION TO SPSMEDICAL SPORVIEW BACTERIAL SPORE STRIP
K041099 · FRC
Spsmedical Supply Corp.
General Hospital · 10d
Cleared May 05, 2004
COOLAN 300
K030810 · GEX
Coolanalgesia , Ltd.
General & Plastic Surgery · 419d
Cleared May 05, 2004
STIMULONG PLUS CATHETER SET MODEL, VARIOUS
K033018 · CAZ
Pajunk GmbH
Anesthesiology · 222d
Cleared May 05, 2004
DXL CALSCAN
K033550 · KGI
Demetech AB
Radiology · 175d
Cleared May 05, 2004
GORE TRI-LOBE BALLOON CATHETER
K033670 · DQY
W.L. Gore & Associates, Inc.
Cardiovascular · 163d
Cleared May 05, 2004
EFLOW ELECTRONIC INHALER/NEBULIZER
K033833 · CAF
Pari Innovative Manufacturers, Inc.
Anesthesiology · 147d