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
90649–90672 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jan 12, 1998
KRONNER LOW PROFILE SCOPE HOLDER
K973543 · GCJ
Kronner Prototypes, Inc.
General & Plastic Surgery · 116d
Cleared Jan 12, 1998
SONIX HEARING AID FITTING AND PROGRAMMING SYSTEM
K973880 · ESD
Sonix Technologies, Inc.
Ear, Nose, Throat · 90d
Cleared Jan 12, 1998
LAPAROSCOPIC GASTROSTOMY KIT
K973891 · KNT
Applied Medical Resources
Gastroenterology & Urology · 90d
Cleared Jan 12, 1998
BAUSCH & LOMB2 SENSITIVE EYES MULTI-PURPOSE SOLUTION
K973921 · LPN
Bausch & Lomb, Inc.
Ophthalmic · 89d
Cleared Jan 12, 1998
LUGE GUIDE WIRE
K973945 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 88d
Cleared Jan 12, 1998
ORBITAL RECONSTRUCTION PLATES
K973982 · HRS
Howmedica, Inc.
Orthopedic · 84d
Cleared Jan 12, 1998
VAPR
K974022 · GEI
Mitek Products
General & Plastic Surgery · 90d
Cleared Jan 12, 1998
SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940 ERBIUM CRYSTALASE
K974039 · GEX
Schwartz Electro-Optics, Inc.
General & Plastic Surgery · 88d
Cleared Jan 12, 1998
FS IV MINI C-ARM SYSTEM
K974058 · JAA
Hologic, Inc.
Radiology · 77d