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
91153–91176 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 16, 1998
LITE TOUCH ERBIUM LASER TREATMENT SYSTEM
K974460 · GEX
Lorad Corp.
General & Plastic Surgery · 52d
Cleared Jan 16, 1998
SCANTECH LASER SCANNER
K974633 · GEX
Phantom Technologies, Inc.
General & Plastic Surgery · 35d
Cleared Jan 16, 1998
PDI STERILE LUBRICATING JELLY
K974768 · KMJ
Nice-Pak Products, Inc.
General Hospital · 25d
Cleared Jan 16, 1998
ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM
K974818 · MMI
Radiometer America, Inc.
Chemistry · 24d
Cleared Jan 14, 1998
AKTINA MEDICAL PHYSICS CORPORATION EECTRON BEAM FIELD SHAPING SYSTEM
K973953 · IXI
Aktina Medical Physics Corp.
Radiology · 90d
Cleared Jan 14, 1998
MODEL 37-185
K973960 · LHN
Victoreen, Inc.
Radiology · 90d
Cleared Jan 14, 1998
120 LEAF MULTILEAF COLLIMATOR
K973963 · IYE
Mitsubishi Electronics America, Inc.
Radiology · 90d
Cleared Jan 14, 1998
ENOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K974394 · JTN
Oxoid , Ltd.
Microbiology · 55d
Cleared Jan 13, 1998
JOBST ATHROMBIC PUMP/SLEEVE
K970922 · JOW
Jobst A Beiersdorf Co.
Cardiovascular · 307d
Cleared Jan 13, 1998
PRIMED SHOE COVERS, PRIMED HEAD COVERS
K971076 · FXP
Primeline Medical Products, Inc.
General Hospital · 295d
Cleared Jan 13, 1998
SILICONE ANTIBACTERIAL FOLEY CATHETER
K971627 · MJC
Rochester Medical Corp.
Gastroenterology & Urology · 256d
Cleared Jan 13, 1998
MAGLIFE C
K972535 · MHX
Odam
Cardiovascular · 189d
Cleared Jan 13, 1998
SINGLE LUMEN EMBOLECTOMY CATHETER
K972572 · DXE
American Biomed, Inc.
Cardiovascular · 187d
Cleared Jan 13, 1998
HUBERLOC
K973497 · LJT
Medcare Medical Group, Inc.
General Hospital · 120d
Cleared Jan 13, 1998
TRIAGE STATMETER
K973547 · KHO
Biosite Incorporated
Chemistry · 117d
Cleared Jan 13, 1998
NIHON KOHDEN BSM-1101 AND BSM-1102 PATIENT MONITOR AND ACCESSORIES
K973918 · DRT
Nihon Kohden America, Inc.
Cardiovascular · 90d
Cleared Jan 13, 1998
EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM
K973923 · KWQ
Ebi Electro Biology
Orthopedic · 90d
Cleared Jan 13, 1998
CONNECTA PLUS 1 AND CONNECTA PLUS 3 2-WAY AND 3-WAY STOPCOCKS
K974083 · FMG
Ohmeda Medical
General Hospital · 76d
Cleared Jan 13, 1998
GERMICIDAL CLOTH
K974304 · LRJ
Convatec, A Division of E.R. Squibb &...
General Hospital · 57d
Cleared Jan 13, 1998
KHT SEOAM NEEDLE, HAND ACUPUNCTURE NEEDLE
K974527 · MQX
American Institute of Koryo Hand Therapy
General Hospital · 42d
Cleared Jan 13, 1998
VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS
K974644 · JJX
Johnson & Johnson Clinical...
Chemistry · 32d
Cleared Jan 12, 1998
SONOS 5500 IMAGING SYSTEM
K971116 · ITX
Hewlett-Packard Co.
Radiology · 292d
Cleared Jan 12, 1998
ENCORE LINEAR HIP
K972791 · JDI
Encore Orthopedics, Inc.
Orthopedic · 168d
Cleared Jan 12, 1998
EZ HOLD 1 LBS., EZ HOLD 2 LBS
K973132 · DXC
Tz Medical, Inc.
Cardiovascular · 144d