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
128785–128808 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 10, 1989
HYDRAULIC FOOT OPERATED STOOL
K893598 · GBB
Arthro-Medic, Inc.
General & Plastic Surgery · 154d
Cleared Oct 10, 1989
SCEPTOR-NEW ANTIMICROBIAL AGENT:TICAR/CLAVU ACID
K894189 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 116d
Cleared Oct 10, 1989
CROSS ROUND & SQUARE SPINAL RODS & DIST. SPINAL
K894472 · KWP
Buckman Co., Inc.
Orthopedic · 84d
Cleared Oct 10, 1989
AMMEL PATIENT EXAMINATION GLOVES
K894502 · LYY
Mauricio Menconi
General Hospital · 83d
Cleared Oct 10, 1989
GORE-TEX SURGICAL TAPE
K894580 · FTM
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 78d
Cleared Oct 10, 1989
GYNEGUIDE
K894591 · GEX
Marlo Surgical Technology
General & Plastic Surgery · 78d
Cleared Oct 10, 1989
PT DISTAL TIP CEMENT SPACER
K894708 · JDK
Osteonics Corp.
Orthopedic · 78d
Cleared Oct 10, 1989
CLINIGEN ERYTHROPOIETIN HUMAN SERUM CONTROLS 1,2,3
K894943 · GGT
Amgen, Inc.
Hematology · 68d
Cleared Oct 10, 1989
OPTILASE YAG MODEL 1000 SURGICAL LASER SYSTEM
K894977 · GEX
Trimedyne, Inc.
General & Plastic Surgery · 64d
Cleared Oct 10, 1989
POW-IR TIP
K895073 · GEX
Living Technology, Inc.
General & Plastic Surgery · 57d
Cleared Oct 10, 1989
BIOTRACK HEMOGLOBIN TEST CARTRIDGE
K895101 · KHG
Biotrack, Inc.
Hematology · 56d
Cleared Oct 10, 1989
BIOTRACK PDS MONITOR
K895102 · JJQ
Biotrack, Inc.
Hematology · 56d
Cleared Oct 10, 1989
ARGOS
K895127 · GKZ
Abx, Inc.
Hematology · 54d
Cleared Oct 10, 1989
RUBBER LATEX SURGICAL GLOVES, STERILE
K895448 · KGO
Dah Lee Rubber Industries (Thai) , Ltd.
General Hospital · 32d
Cleared Oct 10, 1989
SHAMROCK SAFETY WINGED INFUSION SET
K895481 · FPA
Ryan Medical, Inc.
General Hospital · 29d
Cleared Oct 10, 1989
SHAMROCK SAFETY BLOOD COLLECTION SET
K895705 · FMI
Ryan Medical, Inc.
General Hospital · 29d
Cleared Oct 06, 1989
INTERMEDICS HIGH TIBIAL OSTEOTOMY SYSTEM
K892228 · HRS
Intermedics Orthopedics
Orthopedic · 184d
Cleared Oct 06, 1989
RESUBMITTED RD1000 NEOPUFF INFANT RESUSCITATOR
K892885 · BTL
Fisher & Paykel Electronics , Ltd.
Anesthesiology · 170d
Cleared Oct 06, 1989
MITEK ANCHOR DRILL
K892903 · HTW
Mitek Surgical Products, Inc.
Orthopedic · 169d
Cleared Oct 06, 1989
FIRST CHOICE (TM)
K893205 · CGA
Polymer Technology Corp.
Chemistry · 163d
Cleared Oct 06, 1989
SPECTRASTIM TM 1000
K893964 · IPF
Therapeutic Technologies, Inc.
Physical Medicine · 126d
Cleared Oct 06, 1989
DEVILBISS MODEL 8500D AND 8500D-608
K894244 · CCQ
Devilbiss Health Care, Inc.
Anesthesiology · 107d
Cleared Oct 06, 1989
PERIODONTAL IRRIGATING SOLUTION-D
K894247 · ELC
Dentsply Intl.
Dental · 107d
Cleared Oct 06, 1989
OHMEDA MODULUS CD ANESTHESIA SYSTEM
K894309 · BSZ
Ohmeda Medical
Anesthesiology · 84d