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
78385–78408 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 15, 2001
SENSITITRE 18 - 24 HOURS SUSCEPTIBILITY PLATES
K011803 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 65d
Cleared Aug 15, 2001
CAPIOX SP PUMP WITH X-COATING PRODUCT CODE: CXSP45X
K012209 · KFM
Terumo Cardiovascular Systems Corp.
Cardiovascular · 30d
Cleared Aug 15, 2001
MODIFICATION TO AEQUALIS SHOULDER SYSTEM
K012212 · KWS
Tornier
Orthopedic · 30d
Cleared Aug 15, 2001
SPIRAL RADIUS 90-D SST SYSTEM
K012273 · MNH
United States Surgical, A Division of...
Orthopedic · 27d
Cleared Aug 15, 2001
MAXIM RPG PS FEMORAL COMPONENT
K012348 · JWH
Biomet, Inc.
Orthopedic · 22d
Cleared Aug 15, 2001
MAC-LINE CO2 NASAL CANNULA SAMPLE LINE
K012391 · CCK
Oridion Medical 1987 , Ltd.
Anesthesiology · 19d
Cleared Aug 15, 2001
ORIDION MAC-LINE ORAL NASAL CANNULA SAMPLE LINE
K012394 · CCK
Oridion Medical 1987 , Ltd.
Anesthesiology · 19d
Cleared Aug 15, 2001
MAC-LINE 02/CO2 NASAL CANNULA SAMPLE LINE
K012395 · CCK
Oridion Medical 1987 , Ltd.
Anesthesiology · 19d
Cleared Aug 15, 2001
ALLFIT IMPLANT SYSTEM, SHORT NECK, MODEL STI RT LENGTH, ALLFIT IMPLANT...
K991822 · DZE
Dr. Ihde Dental AG Switzerland
Dental · 811d
Cleared Aug 14, 2001
NORMED MANDIBULAR FIXATION SYSTEM
K010118 · JEY
Osteomedics, Inc.
Dental · 210d
Cleared Aug 14, 2001
DIATEK CANNON-CATH #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC,...
K010399 · MSD
Diatek, Inc.
Gastroenterology & Urology · 186d
Cleared Aug 14, 2001
BAUMER LOCKING NAIL
K011504 · JDS
Baumer, S.A
Orthopedic · 90d
Cleared Aug 14, 2001
HCG STAT PAK ULTRA-FAST
K011550 · JHI
Chembio Diagnostic Systems, Inc.
Chemistry · 88d
Cleared Aug 14, 2001
SURE CHECK PREGNANCY TEST
K011551 · LCX
Chembio Diagnostic Systems, Inc.
Chemistry · 88d
Cleared Aug 14, 2001
MODEL 235GE-64
K011608 · MOS
Medical Advances, Inc.
Radiology · 81d
Cleared Aug 14, 2001
SUNMAX BLUE NITRILE POWDERED EXAMINATION GLOVES
K011717 · LZA
Sunmax Enterprise Shanghai Co. , Ltd.
General Hospital · 71d
Cleared Aug 14, 2001
ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES
K011721 · KGO
Allegiance Healthcare Corp.
General Hospital · 71d
Cleared Aug 14, 2001
CORERESTORE 2
K011798 · EBF
Sybron Dental Specialties, Inc.
Dental · 67d
Cleared Aug 14, 2001
FHC MICROTARGETING DRIVE SYSTEM
K011992 · HAW
FHC, Inc.
Neurology · 49d
Cleared Aug 14, 2001
CG-3250 MINIRECEIVER
K012187 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 33d
Cleared Aug 14, 2001
MODIFICATION TO: VIEWGT ELECTRONIC PORTAL IMAGING DEVICE (EPID)
K012289 · IYE
Elekta Oncology Systems, Ltd.
Radiology · 25d
Cleared Aug 14, 2001
HNC-127 NEUROVASCULAR ARRAY COIL
K012353 · MOS
Mri Devices Corp.
Radiology · 20d
Cleared Aug 14, 2001
PACEART TX3 CARDIAC EVENT RECORDER
K012407 · DXH
Paceart, Inc.
Cardiovascular · 15d
Cleared Aug 14, 2001
MODEL 6500 UNIPOLAR TEMORARY MYOCARDIAL PACING LEAD
K012452 · LDF
Medtronic Vascular
Cardiovascular · 13d