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
110905–110928 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 14, 1993
KONICA LD-4500 LASER DIGITIZER
K933830 · LMA
Konica Medical Corp.
Radiology · 131d
Cleared Dec 14, 1993
FORCEPS, BIOPSY, GASTROINTESTINAL
K934186 · FCL
Primed Instruments, Inc.
Gastroenterology & Urology · 110d
Cleared Dec 14, 1993
BAGEASY(R) III ADULT DISPOSABLE MANUAL RESUSCITATOR
K934310 · BTM
Respironics, Inc.
Anesthesiology · 104d
Cleared Dec 14, 1993
IMPAX 3000
K934832 · JAK
Heraeus Kulzer, Inc.
Radiology · 67d
Cleared Dec 14, 1993
LASER GAS MIXTURE
K935034 · GEX
Tri-Gas, Inc.
General & Plastic Surgery · 183d
Cleared Dec 13, 1993
MONOCRYSTANT PH/LES CATHETER, MODIFICATION
K914793 · KLA
Synectics-Dantec
Gastroenterology & Urology · 840d
Cleared Dec 13, 1993
MEDSURG MARSHMALLOW TRAY
K920421 · GAT
Medsurg Industries, Inc.
General & Plastic Surgery · 682d
Cleared Dec 13, 1993
STERI-OSS TITANIUM SCREW SERIES IMPLANT
K923484 · DZE
Steri-Oss, Inc.
Dental · 516d
Cleared Dec 13, 1993
RADIONUCLIDE CATHETERS, RNC-A, RNC-G, RNC-U
K923697 · KXK
Radionics, Inc.
Radiology · 507d
Cleared Dec 13, 1993
STRATO MEDICAL SINGLE LUMEN VALVED CATHETER
K924851 · LJS
Strato Medical Corp.
General Hospital · 441d
Cleared Dec 13, 1993
PRACTICE PARTNER
K926315 · LMD
Rs Imaging
Radiology · 363d
Cleared Dec 13, 1993
FEVER MONITORING KIT
K931747 · FLL
Polymedica Healthcare, Inc.
General Hospital · 249d
Cleared Dec 13, 1993
LACERATION TRAY
K932036 · FRG
Clinipad Corp.
General Hospital · 230d
Cleared Dec 13, 1993
MODEL 500-6 RADIATION THERAPY IONIZATION CHAMBER
K932342 · LNN
Victoreen, Inc.
Radiology · 213d
Cleared Dec 13, 1993
BASIC SKIN PREP TRAY
K932361 · FMF
Mcbar Industries
General Hospital · 278d
Cleared Dec 13, 1993
ESPOCAN COMBINED SPINAL/EPIDURAL NEEDLE SET & TRAY
K932400 · BSP
B. Braun of America, Inc.
Anesthesiology · 209d
Cleared Dec 13, 1993
HEARTVIEW(R) CORONARY ANGIOGRAPH DIAGRAM/REPORT SY
K932410 · IZI
Heartware Intl. Corp.
Radiology · 209d
Cleared Dec 13, 1993
PHILIPS GYROSCAN TN5 & TN5 LITE
K932644 · LNH
Philips Medical Systems, Inc.
Radiology · 194d
Cleared Dec 13, 1993
PHILIPS GYROSCAN TN 15
K932645 · LNH
Philips Medical Systems, Inc.
Radiology · 194d
Cleared Dec 13, 1993
CONVENIENCE CONTOUR KITS REDI NURSE SYSTEM
K933151 · FRG
Contour Fabricators of Florida, Inc.
General Hospital · 167d
Cleared Dec 13, 1993
XYZ PADS
K933159 · EFQ
Aso Corp.
General & Plastic Surgery · 167d
Cleared Dec 13, 1993
MEDSCAN 12
K933632 · LMA
Vidar Systems Corp.
Radiology · 139d
Cleared Dec 13, 1993
MODIFICATION OF KENDALL CURASORB CALCIUM ALGINATE WOUND DRESSING
K933689 · KMF
Kendall Healthcare Products Co....
General & Plastic Surgery · 137d
Cleared Dec 13, 1993
CONCEPT ONE
K933777 · IZO
Innerscan, Inc.
Radiology · 132d