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
113041–113064 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 22, 1993
FLUORO-SHIELD RADIATION REDUCTION GLOVES
K920620 · LZC
Acufex Microsurgical, Inc.
General Hospital · 497d
Cleared Jun 22, 1993
TIP & MEMBRANE ASSEMBLY
K921443 · HKX
Bio-Rad
Ophthalmic · 483d
Cleared Jun 22, 1993
COMPACT COTREL -- DUBOUSSET SPINE SYSTEM
K921767 · KWP
Buckman Co., Inc.
Orthopedic · 434d
Cleared Jun 22, 1993
SYNTHES UNIVERSAL SPINE HOOK AND ROD FIXATION SYST
K921948 · KWP
Synthes (Usa)
Orthopedic · 421d
Cleared Jun 22, 1993
EXAMINATION GLOVES POWDER FREE
K923089 · LYY
Glovoco (M) Sdn Bhd
General Hospital · 362d
Cleared Jun 22, 1993
SYNTHES LIMITED CONTACT-DYNAMIC HIP SCREW IMPLANT
K923613 · JDO
Synthes (Usa)
Orthopedic · 336d
Cleared Jun 22, 1993
FOLEY INSERTION TRAY
K923906 · KOD
Kit Pak, Inc.
Gastroenterology & Urology · 322d
Cleared Jun 22, 1993
KIT PAK I.V. START KIT
K924051 · LYY
Kit Pak, Inc.
General Hospital · 314d
Cleared Jun 22, 1993
EEG MODEL 24/32
K924179 · GWQ
Lama Engineering, Inc.
Neurology · 307d
Cleared Jun 22, 1993
CONVATEC LITTLE ONES PEDIATRIC URINE COLLECTION
K924755 · EXI
Convatec, A Division of E.R. Squibb &...
Chemistry · 272d
Cleared Jun 22, 1993
POSSIS MEDICAL MYOPORE BIPOLAR SUTURELESS MYCARDIA
K925099 · DTB
Possis Medical, Inc.
Cardiovascular · 257d
Cleared Jun 22, 1993
STERILE SKIN SCRUB TRAYS
K925216 · LRO
American Healthcare Supply Co., Inc.
General & Plastic Surgery · 249d
Cleared Jun 22, 1993
CARBON DIOXIDE & OXYGEN MONITOR TYPE 1308
K925484 · CCK
Bruel & Kjaer
Anesthesiology · 235d
Cleared Jun 22, 1993
CARDIOMAGIC SOFTWARE
K925639 · DXH
Instromedix, Inc.
Cardiovascular · 225d
Cleared Jun 22, 1993
SERIES V-SCAN RADIOGRAPHIC FILM SCANNER
K925664 · LLZ
Vision Ten, Inc.
Radiology · 224d
Cleared Jun 22, 1993
CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING
K926138 · KRH
Baxter Healthcare Corp
Cardiovascular · 197d
Cleared Jun 22, 1993
OSTEONICS MICROSUTERED FEMORAL COMPONENTES
K926201 · LPH
Osteonics Corp.
General Hospital · 195d
Cleared Jun 22, 1993
INTERSEPT FILTERED CARDIOTOMY RESERVOIR
K926226 · DTZ
Medtronic Vascular
Cardiovascular · 194d
Cleared Jun 22, 1993
ANESTHESIA RESPIRATORY BREATH CIRCUIT PACKS/COMPON
K926454 · CAI
Medical, Inc.
Anesthesiology · 180d
Cleared Jun 22, 1993
MOLLER-WEDEL OPERATING MICROSCOPE
K926513 · FSO
Moeller Microsurgical, Inc.
General & Plastic Surgery · 174d
Cleared Jun 22, 1993
INFRARED EXPOSURE HAND SWITCH
K930049 · IZL
Mid X-Ray, Inc.
Radiology · 168d
Cleared Jun 22, 1993
SURGICAL MESH DELIVERY SYSTEM, GENERAL SURGERY
K930147 · GCJ
Davol, Inc.
General & Plastic Surgery · 161d
Cleared Jun 22, 1993
DRI-VENDT/PROVENT/ACCUVENT ARTERIAL BLOOD GAS KITS
K930286 · CBT
Concord/Portex
Anesthesiology · 152d
Cleared Jun 22, 1993
BARD(R) BLOOD CARDIOPLEGIA HEAT EXCHANGER/TUBE SET
K930299 · DTN
C.R. Bard, Inc.
Cardiovascular · 152d