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
70657–70680 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 21, 2003
BODYGUARD INFUSION SYSTEM
K031749 · FRN
Caesarea Medical Electronics , Ltd.
General Hospital · 77d
Cleared Aug 21, 2003
SHIMADZU COLLIMATOR R-30H
K031771 · IZX
Shimadzu Corp.
Radiology · 73d
Cleared Aug 21, 2003
NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX
K031885 · HBL
Image-Guided Neurologics, Inc.
Neurology · 64d
Cleared Aug 21, 2003
NPAC DIGITAL THERMOMETER, MODELS ET 300, 301, 350, 351
K031907 · FLL
Norm Pacific Automation Corp.
General Hospital · 62d
Cleared Aug 21, 2003
COOLTOUCH INCORPORATED MODELCT3 ND:YAG SURGICAL LASER SYSTEMS
K031954 · GEX
New Star Lasers, Inc.
General & Plastic Surgery · 57d
Cleared Aug 21, 2003
LINVATEC 300W XENON LIGHT SOURCE
K031994 · GCT
Linvatec Corp.
Gastroenterology & Urology · 55d
Cleared Aug 21, 2003
TOXCUP DRUG SCREEN CUP AMP/COC/MET/OPI/PCP/THC
K032057 · DIO
Branan Medical Corp.
Toxicology · 50d
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