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
83353–83376 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 01, 2000
MEDAMICUS EPIDURAL INTRODUCER
K994097 · GZB
Medamicus, Inc.
Neurology · 89d
Cleared Mar 01, 2000
PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICES
K994151 · GAA
Ximed/Prosure/Injectx
General & Plastic Surgery · 83d
Cleared Mar 01, 2000
PHALANGEAL FIXATION SYSTEM
K994232 · HTY
Medcanica, Inc.
Orthopedic · 76d
Cleared Mar 01, 2000
DIMENSION SPECIAL PROTEIN CALIBRATOR
K994291 · JIT
Dade Behring, Inc.
Immunology · 71d
Cleared Mar 01, 2000
DIMENSION C4 FLEX REAGENT CARTRIDGE
K994293 · DBI
Dade Behring, Inc.
Immunology · 71d
Cleared Mar 01, 2000
DIMENSION C3 FLEX REAGENT CARTRIDGE
K994296 · CZW
Dade Behring, Inc.
Immunology · 71d
Cleared Mar 01, 2000
OVUM PICK-UP NEEDLES WITH AQ COATING, ASPIRATION NEEDLES WITH AQ COATING
K994417 · MQE
Cook Urological, Inc.
Obstetrics & Gynecology · 63d
Cleared Feb 29, 2000
SYNTHETIC POWDER FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES
K000071 · LYZ
Shijiazhuang Great Eagle Plastic...
General Hospital · 50d
Cleared Feb 29, 2000
HARDYDISK, NALIDIXIC ACID, 30MCG
K000130 · JTN
Hardy Diagnostics
Microbiology · 42d
Cleared Feb 29, 2000
KIPPMED I.V. MANIFOLD
K000152 · FPA
The Kipp Group
General Hospital · 41d
Cleared Feb 29, 2000
CEMENT IT! UNIVERSAL C&B
K000173 · EMA
Jeneric/Pentron, Inc.
Dental · 40d
Cleared Feb 29, 2000
HARDYDISK TOBRAMYCIN, 10MCG
K000182 · JTN
Hardy Diagnostics
Microbiology · 40d
Cleared Feb 29, 2000
HARDYDISK, STREPTOMYCIN 10MCG
K000201 · JTN
Hardy Diagnostics
Microbiology · 39d
Cleared Feb 29, 2000
TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) CONTROLS
K000230 · JJX
Biosite Incorporated
Chemistry · 33d
Cleared Feb 29, 2000
SECURMIX
K000367 · LHI
Eurospital
General Hospital · 25d
Cleared Feb 29, 2000
CRAFT DUO-VAC SUCTION UNIT AND CRAFT SUCTION UNIT
K000394 · MQG
Rocket Medical Plc
Obstetrics & Gynecology · 22d
Cleared Feb 29, 2000
HYBRID CAPTURE II CT/GC TEST
K981567 · LSL
Digene Corp.
Microbiology · 669d
Cleared Feb 29, 2000
DENTAL IMPLANT
K992937 · DZE
Nobel Biocare Uas, Inc.
Dental · 182d
Cleared Feb 29, 2000
PULPDENT CAVITY PREPARATION II, PULPDENT CAVITY PREPARATION II WUTH FLUORIDE
K994181 · LBH
Pulpdent Corp.
Dental · 81d
Cleared Feb 29, 2000
MODIFICATION OF REGULAR DIAMETER SINGLE STAGE (RDS) TPS DENTAL IMPLANT SYSTEM
K994205 · DZE
Lifecore Biomedical, Inc.
Dental · 90d
Cleared Feb 28, 2000
IMMULITE PHENYTOIN, IMMULITE 2000 PHENYTOIN, CATALOG # LKPN1, LKPN5 & L2KPN2,...
K000006 · DIP
Diagnostic Products Corp.
Toxicology · 56d
Cleared Feb 28, 2000
IMMULITE CARBAMAZEPINE, IMMULITE 2000 CARBAMAZEPINE, CATALOG # LKCB1, LKCB5 &...
K000007 · KLT
Diagnostic Products Corp.
Toxicology · 56d
Cleared Feb 28, 2000
HARDYDISK, PIPERACILLIN, 100MCG
K000183 · JTN
Hardy Diagnostics
Microbiology · 39d
Cleared Feb 28, 2000
BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH THE FASTTAKE COMPACT...
K000318 · JJX
Bionostics, Inc.
Chemistry · 27d