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
137617–137640 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 13, 1987
LIGATURE CARRIER/PACKER, HYDROXYLAPATITE
K874342 · GEJ
Cox-Uphuff Intl.
General & Plastic Surgery · 24d
Cleared Nov 13, 1987
SURGICAL PREP RAZOR
K874370 · LWK
Derma-Safe Co.
General & Plastic Surgery · 18d
Cleared Nov 12, 1987
NOVO BMC-LAB 23, BONE DENSITOMETER
K864299 · KGI
Scan Detectronic Laboratories, Inc.
Radiology · 377d
Cleared Nov 12, 1987
HEARING AID (ALL-IN-THE-EAR)
K873490 · ESD
Kerr Hearing Aid Laboratory
Ear, Nose, Throat · 73d
Cleared Nov 12, 1987
TUBING, POLYETHYLENE
K873597 · DXT
Coeur Laboratories, Inc.
Cardiovascular · 69d
Cleared Nov 12, 1987
DIAMOND-LUSTER DENTAL POLISHING PASTE
K873686 · EJR
Scientific Pharmaceuticals, Inc.
Dental · 59d
Cleared Nov 12, 1987
NOVA STREP A
K873784 · GTZ
Synbiotics Corp.
Microbiology · 56d
Cleared Nov 12, 1987
CLEARFIL PORCELAIN REPAIR SYSTEM
K873886 · EBF
Kuraray Co.
Dental · 50d
Cleared Nov 12, 1987
MODEL A-72, BEHIND-THE-EAR HEARING AID
K874325 · ESD
Audiotone, Inc.
Ear, Nose, Throat · 22d
Cleared Nov 12, 1987
TITANIUM SUCTION TIP
K874401 · EHZ
Implant Innovations International, Inc.
Dental · 15d
Cleared Nov 10, 1987
MODEL 5001 MICROMANIPULATOR FOR USE W/TF-25 CO2
K873246 · GEX
Coherent Medical Group
General & Plastic Surgery · 88d
Cleared Nov 10, 1987
EPI-LOCK T.M. PRIMADERM
K874291 · NAD
Derma-Lock Medical Corp.
General & Plastic Surgery · 21d
Cleared Nov 09, 1987
D.R.P. THREE STEP WOUND DRESSING
K871327 · FRO
Bioderm, Inc.
General & Plastic Surgery · 220d
Cleared Nov 09, 1987
ANTI-INFECTION SHIELD
K872935 · FXX
Stackhouse Assoc.
General Hospital · 105d
Cleared Nov 09, 1987
LIFE-SPAN CABLE
K873361 · IKD
Chemfet Corp.
Physical Medicine · 80d
Cleared Nov 09, 1987
EMDS N-ACETYLPROCAINAMIDE CALIBRATOR #67635/95
K874101 · DLJ
Em Diagnostic Systems, Inc.
Toxicology · 32d
Cleared Nov 06, 1987
MEDTRONIC MODEL 5513 ENDOCARDIAL PACING LEAD
K870885 · DTB
Medtronic Vascular
Cardiovascular · 246d
Cleared Nov 06, 1987
BONE MARROW COLLECTION KIT AND STAND
K871198 · LWE
Baxter Healthcare Corp
General Hospital · 227d
Cleared Nov 06, 1987
GENESIS II
K871697 · DXK
Biosound, Inc.
Cardiovascular · 190d
Cleared Nov 06, 1987
NOVAMETRIX END TIDAL CO2 MONITOR, MODEL 1260
K873149 · CCK
Novametrix Medical Systems, Inc.
Anesthesiology · 87d
Cleared Nov 06, 1987
HAMILTON-THORN MOTILITY ANALYZER HTM-2000
K873172 · GKL
Hamilton Thorne Research
Pathology · 87d
Cleared Nov 06, 1987
SARNS CARDIOPLEGIA/VENT CATHETERS
K873212 · DWF
3M Health Care, Sarns
Cardiovascular · 84d
Cleared Nov 06, 1987
DIGICELL 500
K873252 · GKL
Contraves Medical Instruments, Inc.
Hematology · 81d
Cleared Nov 06, 1987
MICRO-COUNT DIFFHE
K873256 · GKZ
Toni Diagnostics, Inc.
Hematology · 84d