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
104113–104136 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 27, 1995
PURITAN-BENNETT COMPANION 320 I/E
K934804 · BZD
Puritan Bennett Corp.
Anesthesiology · 508d
Cleared Feb 27, 1995
PHYSIO HAB
K941033 · ISD
Longo Industries
Physical Medicine · 360d
Cleared Feb 27, 1995
MOTIVATOR FTR 2000
K942229 · IKK
Hogan & Hartson
Physical Medicine · 297d
Cleared Feb 27, 1995
ULTIMA 2 DENTAL CHAIR
K942870 · KLC
Dentech Corp.
Dental · 255d
Cleared Feb 27, 1995
DISPOSABLE TEMPERATURE PROBE COVER
K942905 · FMT
Arbo Medical, Inc.
General Hospital · 251d
Cleared Feb 27, 1995
HASSON STABILIZING ACCESS CANNULA (SAC)
K942973 · HET
Entec Corp.
Obstetrics & Gynecology · 252d
Cleared Feb 27, 1995
LAKE STAGEZERO(TM) AIR FLOTATION BED
K943162 · FNM
Lake Medical Products, Inc.
General Hospital · 241d
Cleared Feb 27, 1995
CLINITRON ELEXIS
K943385 · INX
Ssi Medical Services, Inc.
Physical Medicine · 229d
Cleared Feb 27, 1995
STERILE WATER
K943773 · JOL
Medline Industries, Inc.
General Hospital · 209d
Cleared Feb 27, 1995
PRO-CRYLIC RESIN, TECHNICOLOR PRE-MIX MONOMER
K943905 · EBI
Professional Positioners, Inc.
Dental · 200d
Cleared Feb 27, 1995
BIAFINE
K943910 · MGQ
Laboratoire Medix
General & Plastic Surgery · 200d
Cleared Feb 27, 1995
R&D BATTERIES PART NOS. 5141, 5067, 5118, 5277
K944390 · FCO
R & D Batteries, Inc.
Gastroenterology & Urology · 173d
Cleared Feb 27, 1995
BRANEMARK SYSTEM 17 ANGULATED ABUTMENT
K944962 · DZE
Nobelpharma USA, Inc.
Dental · 143d
Cleared Feb 27, 1995
STERI-LUB LUBRICATION GEL
K944969 · KMJ
Horizon Medical, Inc.
General Hospital · 139d
Cleared Feb 27, 1995
SUTTER MODEL 6000 HAND CPM DEVICE
K945221 · BXB
Sutter Corp.
Physical Medicine · 124d
Cleared Feb 27, 1995
SSV PHONATE(TM) SHILEY SPEAKING VALVE
K945406 · BTO
Mallinckrodt Medical Tpi, Inc.
Anesthesiology · 116d
Cleared Feb 27, 1995
SSVO PHONATE(TM) SHILEY SPEAKING VALVE WITH OXYGEN PORT
K945407 · BTO
Mallinckrodt Medical Tpi, Inc.
Anesthesiology · 116d
Cleared Feb 27, 1995
UNICATH LLU ANGIOGRAPHIC SYSTEM
K945449 · IZI
Xre Corp.
Radiology · 112d
Cleared Feb 27, 1995
HI DENSE, GLASS IONOMER SILVER REINFORCED RESTORATIVE
K945451 · EMA
Shofu Dental Corp.
Dental · 112d
Cleared Feb 27, 1995
DYNAMICAIRE(TM) SLEEP SURFACE, ZONEAIR(TM) SLEEP SURFACE
K945729 · IOQ
Hill-Rom, Inc.
Physical Medicine · 97d
Cleared Feb 27, 1995
DERMAGRAN WOUND CLEANSER WITH ZINC
K945802 · KMF
Derma Sciences, Inc.
General & Plastic Surgery · 91d
Cleared Feb 27, 1995
R&D PART NOS. 5443, 5322, 5448, 5492
K945869 · FCO
R & D Batteries, Inc.
Gastroenterology & Urology · 88d
Cleared Feb 27, 1995
R&D PART NOS. 5339, 5510, 5514
K945871 · FCO
R & D Batteries, Inc.
Gastroenterology & Urology · 88d
Cleared Feb 27, 1995
IVALON EXTERNAL SPONGE
K946015 · NAB
Ivalon
General & Plastic Surgery · 80d