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
110089–110112 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 09, 1994
WHIS-RAD TUBSTAND STRUCTURE/MOBILE PATIENT TROLLEY
K935649 · KPR
Bennett X-Ray Corp.
Radiology · 78d
Cleared Feb 09, 1994
SHAVE PREP TRAY
K935739 · KCT
Cush Medical Products
General Hospital · 70d
Cleared Feb 09, 1994
GLASSER SUTURE NEEDLE
K935878 · GCJ
Advanced Surgical, Inc.
General & Plastic Surgery · 62d
Cleared Feb 09, 1994
CENTERMARK SECURING WINGS
K940127 · KMK
Menlo Care, Inc.
General Hospital · 30d
Cleared Feb 08, 1994
ASTRA TECH IMPLANTS-DENTAL SYSTEM
K931767 · DZE
Astra Tech, Inc.
Dental · 306d
Cleared Feb 07, 1994
END TIDAL CO2 OPTION B
K930524 · CCK
Medical Data Electronics
Anesthesiology · 370d
Cleared Feb 07, 1994
RIGHT ATRIAL CATHETER
K930630 · LJS
Akcess Medical Products, Inc.
General Hospital · 364d
Cleared Feb 07, 1994
IMPLEX ACETABULAR CUP SCREW SYSTEM
K931187 · HWC
Implex Corp.
Orthopedic · 335d
Cleared Feb 07, 1994
TROCAR SLEEVE
K931561 · HET
L.A.S.E.R., Inc.
Obstetrics & Gynecology · 314d
Cleared Feb 07, 1994
CARAPACE DEBRIDEMENT KITS
K931669 · FRG
Carapace, Inc.
General Hospital · 307d
Cleared Feb 07, 1994
BATTERY PACK 1017LA
K931716 · DSI
Portable Power Systems, Inc.
Cardiovascular · 307d
Cleared Feb 07, 1994
CARAPACE STILLWATER BOWL SET
K931820 · LRO
Carapace, Inc.
General & Plastic Surgery · 305d
Cleared Feb 07, 1994
THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZER
K931872 · FLF
American Sterilizer Co.
General Hospital · 299d
Cleared Feb 07, 1994
ENDPOINT 500 PERACETIC ACID TEST INDICATORS
K931935 · JOJ
Minntech Corp.
General Hospital · 294d
Cleared Feb 07, 1994
PROXIMATE ARTICULATING LINEAR STAPLER
K932434 · OCW
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology · 263d
Cleared Feb 07, 1994
THEREX R-PORT
K932671 · LJT
Therex Corp.
General Hospital · 250d
Cleared Feb 07, 1994
SHIMADZU DIGITAL SUBSTRACTION SYST DAR-2400 SERIES
K933472 · JAA
Shimadzu Corp.
Radiology · 207d
Cleared Feb 07, 1994
MINIMAX PLUS HOLLOW FIBER OXYGENATOR (WITH OR WITHOUT MEDTRONIC/CARMEDA...
K933586 · DTZ
Medtronic Vascular
Cardiovascular · 196d
Cleared Feb 07, 1994
BACT/ALERT BLOOD COLLECTION ADAPTER CAP AND INSERT
K933939 · GIM
Organon Teknika Corp.
Microbiology · 179d
Cleared Feb 07, 1994
I SIGHT 2020 ENDOSCOPIC & SURGICAL VIDEO CAMERA
K934097 · GCJ
Sharplan Lasers, Inc.
General & Plastic Surgery · 168d
Cleared Feb 07, 1994
INTERTIP INFUSION SET
K934204 · HQE
Oasis Medical, Inc.
Ophthalmic · 161d
Cleared Feb 07, 1994
INNERDYNE REMOTE RADIALLY EXPANDING DILATOR REMOTE R.E.D.
K934377 · FGE
Interventional Thermodynamics, Inc.
Gastroenterology & Urology · 151d
Cleared Feb 07, 1994
HEARIT
K934805 · LZI
Je Liss & Co., Inc.
Ear, Nose, Throat · 123d
Cleared Feb 07, 1994
EPM-3300 VIDEO PROCESSOR
K934918 · FET
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 115d