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
71785–71808 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 21, 2003
NEUROVASCULAR ARRAY COIL, MODEL NVA-127-8
K032090 · MOS
Mri Devices Corp.
Radiology · 45d
Cleared Aug 21, 2003
NOMOS CORVUS 5.0M
K032209 · MUJ
Nomos Corp.
Radiology · 34d
Cleared Aug 21, 2003
14G CORMARK BIOPSY SITE IDENTIFIER
K032217 · FZP
Artemis Medical, Inc.
General & Plastic Surgery · 31d
Cleared Aug 21, 2003
MODEL 120 SERIES MATERNAL/FETAL MONITOR
K032252 · HGM
Ge Medical Systems Information...
Obstetrics & Gynecology · 30d
Cleared Aug 21, 2003
MODIFICATION TO HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM
K032282 · EZX
Implex Corp.
General & Plastic Surgery · 28d
Cleared Aug 21, 2003
OLYMPUS PREALBUMIN CALIBRATOR, ODR3029
K032285 · JIT
Olympus America, Inc.
Chemistry · 28d
Cleared Aug 21, 2003
GENESIS II POSTERIOR STABILIZED HIGH FLEXION ARTICULAR INSERT
K032295 · JWH
Smith & Nephew, Inc.
Orthopedic · 27d
Cleared Aug 21, 2003
NEOGEN ONE, CLOSED WOUND DRAIN SYSTEM, PART NUMBER: NG9900
K032301 · OMP
Neogen Technologies, Inc.
General & Plastic Surgery · 27d
Cleared Aug 21, 2003
BIOMARC TISSUE MARKER
K032347 · GDW
Carbon Medical Technologies, Inc.
General & Plastic Surgery · 22d
Cleared Aug 21, 2003
ROCHE DIAGNOSTICS HITACHI BICARBONATE LIQUID
K032377 · KHS
Roche Diagnostics Corp.
Chemistry · 20d
Cleared Aug 21, 2003
RINGLOC 36MM LINE AND MODULAR FEMORAL HEADS
K032396 · JDI
Biomet, Inc.
Orthopedic · 17d
Cleared Aug 21, 2003
QSC-127 SHOULDER ARRAY COIL SET
K032429 · MOS
Mri Devices Corp.
Radiology · 15d
Cleared Aug 21, 2003
MODIFICATION TO: STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115 & 100C-230
K032452 · GEI
Stellartech Research Corp.
General & Plastic Surgery · 10d
Cleared Aug 21, 2003
TOSHIBA EXCELART VANTAGE XGV/AGV MRI DIAGNOSTIC SYSTEM, MODELS MRT-1503/P3...
K032490 · LNH
Toshiba America Medical Systems, In.C
Radiology · 9d
Cleared Aug 21, 2003
ARTHROCARE SYSTEM
K032504 · GEI
Arthrocare Corp.
General & Plastic Surgery · 8d
Cleared Aug 20, 2003
MODIFICATION ORIA SPINAL SYSTEM
K023884 · KWP
Ortho Tec, LLC
Orthopedic · 272d
Cleared Aug 20, 2003
SHAPE-LOCKABLE ENDOSCOPIC OVERTUBE
K023902 · FED
Usgi Medical, Inc.
Gastroenterology & Urology · 271d
Cleared Aug 20, 2003
DUET SYSTEM
K030192 · JOY
Bioview , Ltd.
Hematology · 211d
Cleared Aug 20, 2003
CRYOTRON 2 CRYOTHERAPY DEVICE
K030281 · MLY
Cryonic Medical North America
Physical Medicine · 205d
Cleared Aug 20, 2003
QUANTIX/OR DEVICE
K030357 · DPW
Cardiosonix, Ltd.
Cardiovascular · 198d
Cleared Aug 20, 2003
ISM1+, IMS2+, AND UTM+
K030490 · MQL
Medicult A/S
Obstetrics & Gynecology · 187d
Cleared Aug 20, 2003
PERFECT CAPSULE
K030957 · HQC
Milvella Pty. , Ltd.
Ophthalmic · 146d
Cleared Aug 20, 2003
S & C -BRACKET ADHESIVES
K031420 · DYH
S & C Polymer GmbH
Dental · 107d
Cleared Aug 20, 2003
NORTHSTAR LIDOCAINE IONTOPHORETIC CONTROLLER (NORTHSTAR CONTROLLER-D)
K031551 · KTB
Vyteris, Inc.
Physical Medicine · 93d