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
70201–70224 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 20, 2003
ARAMIS II DERMATOLOGICAL LASER
K032260 · GEX
Quantel Medical
General & Plastic Surgery · 121d
Cleared Nov 20, 2003
CALCIGEN PSI BONE GRAFT SUBSTITUTE
K032286 · MQV
Biomet Orthopedics, Inc.
Orthopedic · 119d
Cleared Nov 20, 2003
DORO RADIOLUCENT HEADREST SYSTEM AND HORSESHOE HEADRESTS,AND NON-RADIOLUCENT...
K032331 · HBL
Pro-Med Instruments GmbH
Neurology · 114d
Cleared Nov 20, 2003
QUASAR, MODEL MD21
K032379 · ILY
Quantum Skincare, Inc.
Physical Medicine · 111d
Cleared Nov 20, 2003
TEMPORARY TRANSVENOUS PACEMAKER PLACEMENT ASSIST DEVICE
K032613 · LDF
Peter M. Rothenberg, M.D.
Cardiovascular · 87d
Cleared Nov 20, 2003
PLASTALGIN AND PLASTALGIN ORTHO
K032708 · ELW
Septodont
Dental · 79d
Cleared Nov 20, 2003
UCR SPINAL SYSTEM
K032739 · MNI
Seaspine
Orthopedic · 77d
Cleared Nov 20, 2003
NEUROLASE, MODELS 150V, 150C, 1064
K032787 · ILY
Spectrum Laser & Technologies
Physical Medicine · 73d
Cleared Nov 20, 2003
BI-ANGULAR SHOULDER SYSTEM
K032895 · MBF
Biomet, Inc.
Orthopedic · 64d
Cleared Nov 20, 2003
FUGUAN (BRAND) POWDERED VINYL PATIENT EXAMINATION GLOVES
K032907 · LYZ
Shijiazhuang Fuguan Plastic Products...
General Hospital · 64d
Cleared Nov 20, 2003
FUGUAN (BRAND) POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K032908 · LYZ
Shijiazhuang Fuguan Plastic Products...
General Hospital · 64d
Cleared Nov 20, 2003
EPI-SCAN, MODEL P 100
K032935 · GZO
Edx Epi-Scan, Inc.
Neurology · 59d
Cleared Nov 20, 2003
BRIGHTWAY BRAND LATEX EXAMINATION GLOVE-(POWDERED, STERILE), CONTAINING 150...
K032938 · LYY
Brightway Holdings Sdn. Bhd.
General Hospital · 59d
Cleared Nov 20, 2003
BRIGHTWAY BRAND LATEX EXAMINATION GLOVE-(POWDER FREE, STERILE) CONTAINING 50...
K032940 · LYY
Brightway Holdings Sdn. Bhd.
General Hospital · 59d
Cleared Nov 20, 2003
SSS, MODEL 1072001 (STANDARD 4-HOLE MODEL) & 1072002 (STANDARD 2-HOLE MODEL)
K032995 · ELC
Micron Corp.
Dental · 56d
Cleared Nov 20, 2003
TLC MODELS ULK-H AND ULT-H INFRARED LAMPS
K033035 · ILY
Tlc Marketing, Inc.
Physical Medicine · 52d
Cleared Nov 20, 2003
DEROYAL SURGICAL GOWNS, STERILE, NON-STERILE
K033057 · FYA
Deroyal
General Hospital · 52d
Cleared Nov 20, 2003
VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER CONSOLE
K033237 · GEX
Vascular Solutions, Inc.
General & Plastic Surgery · 45d
Cleared Nov 20, 2003
MODIFICATION TO RESQPOD CIRCULATORY ENHANCER
K033401 · BWF
Advanced Circulatory Systems, Inc.
Anesthesiology · 27d
Cleared Nov 20, 2003
LSO PET/CT HIREZ AND LSO PET/CT 16 HIREZ
K033431 · KPS
Cti Pet Systems, Inc.
Radiology · 23d
Cleared Nov 20, 2003
BRUNO ELECTRA-RIDE ELITE, MODEL SRE-2000
K033438 · ILK
Bruno Independent Living Aids, Inc.
Physical Medicine · 23d
Cleared Nov 20, 2003
MODIFICATION TO CALIBRATOR FOR AUTOMATIC SYSTEMS (CFAS)
K033501 · JIX
Roche Diagnostics Corp.
Chemistry · 15d
Cleared Nov 20, 2003
LIGHTSPEED 6.0 CT SCANNER SYSTEM
K033502 · JAK
Ge Medical Systems, LLC
Radiology · 15d
Cleared Nov 20, 2003
REPROCESSED SINGLE USE DEVICES BIOPSY FORCEPS
K033593 · NLU
Clearmedical, Inc.
Gastroenterology & Urology · 7d