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
120337–120360 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 02, 1991
LUMATAG T4 CHEMILUMINESCENCE ASSAY
K911985 · CDX
London Diagnostics, Inc.
Chemistry · 88d
Cleared Aug 02, 1991
FRASTEC DRYNET, BRIDAL VEIL, VARIOUS SIZES
K912022 · NAD
Fraass Survival Systems, Inc.
General & Plastic Surgery · 87d
Cleared Aug 02, 1991
MODIFIED LIFECARE MODEL 175 INFUSER
K912092 · FRN
Abbott Laboratories
General Hospital · 81d
Cleared Aug 02, 1991
CARDIAC SPECT PALLET
K912286 · IYZ
Siemens Gammasonics, Inc.
Radiology · 71d
Cleared Aug 02, 1991
PEACE MODEL 100 CUFF MONITOR
K912352 · BSK
Peace Medical, Inc.
Anesthesiology · 66d
Cleared Aug 02, 1991
ECT CARBON FIBER PALLET, MODIFICATION
K912481 · IYZ
Siemens Gammasonics, Inc.
Radiology · 71d
Cleared Aug 02, 1991
GAMMAMED 12IT HIGH DOSE RATE REMOTE AFTERLOADER
K912555 · JAQ
Rts Technology, Inc.
Radiology · 52d
Cleared Aug 02, 1991
TANGENT IV
K912586 · IXR
Fischer Imaging Corp.
Radiology · 51d
Cleared Aug 02, 1991
MOUTH TO MASK RESUSCITATOR
K912625 · BTM
Vital Signs, Inc.
Anesthesiology · 50d
Cleared Aug 02, 1991
BOLUS XENON CIRCUIT
K912626 · IYT
Vital Signs, Inc.
Radiology · 50d
Cleared Aug 02, 1991
MONOSCOPY(TM) BRAND, DUAL SUCTION/IRRIGATION CONTR
K912750 · GCJ
Dexide, Inc.
General & Plastic Surgery · 42d
Cleared Aug 02, 1991
LATEX EXAMINATION GLOVES
K912988 · LYY
La Glove (M) Sdn. Bhd.
General Hospital · 28d
Cleared Aug 02, 1991
HEART NEBULIZER POLE CLAMP
K913000 · CAF
B&B Medical Technologies, Inc.
Anesthesiology · 25d
Cleared Jul 31, 1991
OMEGA ANGIOSCOPES (OMEGASCOPES)
K911090 · LYK
Omega Universal Technologies, Ltd.
Cardiovascular · 142d
Cleared Jul 31, 1991
ICON TELERADIOLOGY SYSTEM
K911752 · LLZ
Icon Medical Systems, Inc.
Radiology · 104d
Cleared Jul 31, 1991
DEVILBISS MODEL 5000
K911896 · CAF
Devilbiss Health Care, Inc.
Anesthesiology · 96d
Cleared Jul 31, 1991
ZOLL PD-1400 PACER/DEFIBRILLATOR
K911956 · DRO
Zmi Corp.
Cardiovascular · 90d
Cleared Jul 31, 1991
CODMAN SKULL CLAMP
K912011 · HBL
Codman & Shurtleff, Inc.
Neurology · 86d
Cleared Jul 31, 1991
MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM
K912582 · DHB
Ciba Corning Diagnostics Corp.
Immunology · 49d
Cleared Jul 31, 1991
HEARING AID, UNITRON MODEL UIK
K912870 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 33d
Cleared Jul 31, 1991
E.T. TAPE II
K912884 · CBH
B&B Medical Technologies, Inc.
Anesthesiology · 30d
Cleared Jul 31, 1991
MONOSCOPY(TM) BRAND, ELECTROSURGICAL RAKE
K913104 · GCJ
Dexide, Inc.
General & Plastic Surgery · 19d
Cleared Jul 31, 1991
CODMAN LHALO SPLIT RING RETRACTOR SYSTEM
K913233 · GZT
Codman & Shurtleff, Inc.
Neurology · 9d
Cleared Jul 30, 1991
QSI 9500
K904294 · OLU
Quantified Signal Imaging, Inc.
Neurology · 314d