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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
161377–161400 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 19, 1982
SLIMTRONICS 2000
K812984 · IPF
Ems Dist.
Physical Medicine · 85d
Cleared Jan 19, 1982
RDP-2000
K813158 · JAA
Machlett Laboratories, Inc.
Radiology · 64d
Cleared Jan 19, 1982
CONPHAR OTOSCOPE/OPTHALMASCOPE
K813299 · ERA
Conphar, Inc.
Ear, Nose, Throat · 57d
Cleared Jan 19, 1982
CONPHAR OTOSCOPE
K813305 · ERA
Conphar, Inc.
Ear, Nose, Throat · 57d
Cleared Jan 19, 1982
POST-AURICULAR HEARING AID MODEL P-101
K813329 · ESD
Telesonic, Inc.
Ear, Nose, Throat · 56d
Cleared Jan 19, 1982
POST-AURICULAR HEARING AID MODEL S-101
K813330 · ESD
Telesonic, Inc.
Ear, Nose, Throat · 56d
Cleared Jan 19, 1982
MEDICAL TAPE (MULTIPLE)
K813364 · KGX
Cederroth, Inc. USA
General & Plastic Surgery · 50d
Cleared Jan 19, 1982
VERI/DFS TM #817
K813515 · GZI
Verite
Neurology · 35d
Cleared Jan 19, 1982
AUDITORY STIMULATOR
K813557 · ETS
Western Advanced Technology, Inc.
Ear, Nose, Throat · 28d
Cleared Jan 19, 1982
BK-6453 RIMMED ACRYLIC LAP TRAY KIT
K813627 · KNO
Fred Sammons, Inc.
Physical Medicine · 21d
Cleared Jan 19, 1982
BK-7182 INSTANT COLD PACK
K813628 · IMD
Fred Sammons, Inc.
Physical Medicine · 21d
Cleared Jan 19, 1982
BK-6111 HI-D TRANSFER BOARD
K813629 · IKX
Fred Sammons, Inc.
Physical Medicine · 21d
Cleared Jan 19, 1982
BK-1129 BOTTLE STRAW
K813630 · ILC
Fred Sammons, Inc.
Physical Medicine · 21d
Cleared Jan 19, 1982
JAR HOLDER & OPENER
K813631 · IKW
Fred Sammons, Inc.
Physical Medicine · 21d
Cleared Jan 19, 1982
COLOR CODED WEIGHT CUFFS
K813632 · IOD
Fred Sammons, Inc.
Physical Medicine · 21d
Cleared Jan 19, 1982
MODELING COMPOUND AND FOAM EXERCISER
K813633 · ION
Fred Sammons, Inc.
Physical Medicine · 21d
Cleared Jan 19, 1982
ONE HANDED SHOE FASTENER
K813634 · ILD
Fred Sammons, Inc.
Physical Medicine · 21d
Cleared Jan 19, 1982
CHILDS TOILET TRAINER HYGIENE AIDS
K813635 · ILS
Fred Sammons, Inc.
Physical Medicine · 21d
Cleared Jan 19, 1982
BK-6470 ADJUSTABLE ELEVATING WHEELCHAIR
K813636 · KNN
Fred Sammons, Inc.
Physical Medicine · 21d
Cleared Jan 18, 1982
HI-TEMP CARDIOVASCULAR CAUTERY
K812760 · GEI
Key Medical, Inc.
General & Plastic Surgery · 109d
Cleared Jan 18, 1982
COAT-A-COUNT FREE & TOTAL ESTRIOL KIT
K812768 · CGI
Diagnostic Products Corp.
Chemistry · 105d
Cleared Jan 18, 1982
P.E.T.
K812793 · DXH
Hospital Equipment Service
Cardiovascular · 104d
Cleared Jan 18, 1982
APC IMPLANTABLE PACING LEADS
K812807 · DTB
American Pacemaker Corp.
Cardiovascular · 104d
Cleared Jan 18, 1982
APC IMPLANTABLE PACING LEAD
K812830 · DTB
American Pacemaker Corp.
Cardiovascular · 102d