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
82849–82872 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Feb 28, 2000
MODIFICATION TO T-REX BIOPSY FORCEPS
K000409 · DWZ
Boston Scientific Corp
Cardiovascular · 20d
Cleared Feb 28, 2000
MEDI-CULT SPERM FREEZE MEDIUM
K991333 · MQL
Medicult A/S
Obstetrics & Gynecology · 315d
Cleared Feb 28, 2000
MEDI-CULT FREEZING & THAWING PACKS
K991335 · MQL
Medicult A/S
Obstetrics & Gynecology · 315d
Cleared Feb 28, 2000
TRIPLE-FIX SPINAL FIXATION SYSTEM
K992147 · MNI
Advanced Spine Technology, Inc.
Orthopedic · 249d
Cleared Feb 28, 2000
NEURO URODYNAMIC SUITE, MODEL 9032E0101
K992715 · FEN
Medtronic Functional Diagnostics A/S
Gastroenterology & Urology · 200d
Cleared Feb 28, 2000
ZOLL M SERIES ETCO2 OPTION
K993036 · MKJ
Zoll Medical Corp
Cardiovascular · 172d
Cleared Feb 28, 2000
DRYSPOT E.COLI 0157 KIT
K993401 · GNA
Oxoid , Ltd.
Microbiology · 143d
Cleared Feb 28, 2000
BLACKSTONE SPINAL FIXATION SYSTEM
K994217 · MNH
Blackstone Medical, Inc.
Orthopedic · 75d
Cleared Feb 28, 2000
EMBRYON TRANSFER CATHETERS/SETS
K994327 · MQF
Rocket Medical Plc
Obstetrics & Gynecology · 68d