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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
152881–152904 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 30, 1984
INFANT STAR VENTILATOR
K840865 · CBK
Infrasonics Corp.
Anesthesiology · 63d
Cleared Apr 30, 1984
FACTOR DEFICIENT SUBSTRATE PLASMA II
K840927 · GGP
Diatech, Inc.
Hematology · 59d
Cleared Apr 30, 1984
FACTOR DEFICIENT SUBSTRATE PLASMA VIII
K840928 · GGP
Diatech, Inc.
Hematology · 59d
Cleared Apr 30, 1984
PROVIDER INFUSION SET
K841017 · FRN
Pancretec, Inc.
General Hospital · 52d
Cleared Apr 30, 1984
SHERIDAN YSI/SONATEMP
K841098 · BZT
Sheridan Catheter Corp.
Anesthesiology · 48d
Cleared Apr 30, 1984
NEUROTRAC
K841110 · GWK
Interspec, Inc.
Neurology · 76d
Cleared Apr 30, 1984
C-18
K841267 · EBF
Pentron Corp.
Dental · 35d
Cleared Apr 30, 1984
CALCIUM CHLORIDE
K841522 · GGW
Diatech, Inc.
Hematology · 18d
Cleared Apr 30, 1984
COMMUNI-TRACH TUBE
K841546 · BTO
Implant Technology, Inc.
Anesthesiology · 14d
Cleared Apr 30, 1984
UNIFILTER ANESTHESIA & RESPIRATORY FILT
K841581 · CAH
Dupaco, Inc.
General Hospital · 13d
Cleared Apr 27, 1984
HYDRON WOUND DRESSING FAST SEAT KIT
K832699 · FRO
National Patent Development Corp.
General & Plastic Surgery · 261d
Cleared Apr 27, 1984
STERILE SUTURE BOOTS
K834135 · KDD
Devon Industries, Inc.
General & Plastic Surgery · 148d
Cleared Apr 27, 1984
PICKER MYELOGRAM TRAY-PMS MYELOGRAM
K841217 · FMI
Professional Medical Systems
General Hospital · 36d
Cleared Apr 26, 1984
OFTALMOGRAF
K833024
Universal Instruments Corp.
Ophthalmic · 233d
Cleared Apr 25, 1984
BLOOD MONITOR BMM 10-4
K831404 · LLB
Gambro, Inc.
Gastroenterology & Urology · 359d
Cleared Apr 25, 1984
SHARPLAN #734 LASER SURGICAL UNIT
K832550 · GEX
Laser Industries , Ltd.
General & Plastic Surgery · 268d
Cleared Apr 25, 1984
ENDO BITE BLOCK
K833491 · KTI
American Endoscopy, Inc.
Ear, Nose, Throat · 201d
Cleared Apr 25, 1984
LIGHT CURED RESIN BONDED CERAMIC
K833797 · EBF
3M Company
Dental · 176d
Cleared Apr 25, 1984
SDI C-FLEX STERILE LIGHT HANDLE
K834239
Sterile Design, Inc.
General & Plastic Surgery · 141d
Cleared Apr 25, 1984
SDL-30
K834280 · IYO
Shimadzu Corp.
Radiology · 163d
Cleared Apr 25, 1984
MACH I ELECTROSURGERY HAND CONTROL
K834434 · GEI
Surgical Products Corp.
General & Plastic Surgery · 128d
Cleared Apr 25, 1984
O'NEIL OBSTETRIC CUP
K840008 · HDB
Go Medical Industries Pty. , Ltd.
Obstetrics & Gynecology · 112d
Cleared Apr 25, 1984
VILENE SURGICAL MASK 5505
K840090
Hall-Tech
General & Plastic Surgery · 106d
Cleared Apr 25, 1984
TUBE-BANDAGE FOR HUMAN DIGITS 200
K840107 · FQM
Zens Health Care Products
General Hospital · 106d