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
115297–115320 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 23, 1992
SUNGLASSES, NON PRESCRIPTION
K920672 · HQY
Daystone Intl. Corp.
Ophthalmic · 283d
Cleared Nov 23, 1992
HOLLOW MOTOR DRIVE UNIT W/ TORQUE CONTROLLER
K920707 · MCW
Devices For Vascular Intervention, Inc.
Cardiovascular · 279d
Cleared Nov 23, 1992
INMAN MEDICAL OIL EMULSION DRESSING
K921290 · FRO
Inman Medical Corp.
General & Plastic Surgery · 257d
Cleared Nov 23, 1992
YSI MODELS 4400 FOLEY CATHETER TEMPERATURE PROBES
K921561 · EZL
Ysis, Inc.
Gastroenterology & Urology · 236d
Cleared Nov 23, 1992
ENDOSCOPE
K921883 · GCM
Optimed Technologies, Inc.
Gastroenterology & Urology · 216d
Cleared Nov 23, 1992
LORAD DIGITAL SPOT MAMMOGRAPHY
K921962 · IZH
Lorad Medical Systems, Inc.
Radiology · 210d
Cleared Nov 23, 1992
UNIPOLAR ATRIAL TEMPORARY PACING LEAD, MODEL 6492
K922182 · LDF
Medtronic Vascular
Cardiovascular · 196d
Cleared Nov 23, 1992
UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD MOD. 6491
K922268 · LDF
Medtronic Vascular
Cardiovascular · 193d
Cleared Nov 23, 1992
UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE, 6493
K922269 · LDF
The Heart Valve Div. Medtronic...
Cardiovascular · 193d
Cleared Nov 23, 1992
TUBE GRIP
K922404 · KRI
Georgia Medical Products, Inc.
Cardiovascular · 186d
Cleared Nov 23, 1992
SYNCHRON TOTAL PROTEIN TEST --MODIFIED
K922467 · CEK
Beckman Instruments, Inc.
Chemistry · 193d
Cleared Nov 23, 1992
TRANSORB(TM) ULCER & WOUND DRESSING
K922666 · NAE
Brady Medical Products Co.
General & Plastic Surgery · 179d
Cleared Nov 23, 1992
SPARTA WET DRESSING, SODIUM CHLORIDE
K922729 · FRO
Sparta Surgical Corp.
General & Plastic Surgery · 171d
Cleared Nov 23, 1992
YSI MODELS 4700 FOLEY CATHETER TEMPERATURE PROBES
K922821 · EZL
Yellow Springs Instrument Co., Inc.
Gastroenterology & Urology · 165d
Cleared Nov 23, 1992
AUTOLOGOUS BLOOD COLLECTION SET
K923016 · CAC
Advanced Haemotechnologies
Anesthesiology · 153d
Cleared Nov 23, 1992
OPERATING SCISSORS FOR LAPAROSCOPIC SURGERIES
K923055 · GCJ
Numed Technologies, Inc.
General & Plastic Surgery · 152d
Cleared Nov 23, 1992
CLINISORB
K923115 · NAB
Hermitage Hospital Products, Inc.
General & Plastic Surgery · 151d
Cleared Nov 23, 1992
NICOLET ARK SYSTEM
K923315 · GWF
Nicolet Instrument Corp.
Neurology · 139d
Cleared Nov 23, 1992
OPERATING ROOM NEEDLE COUNTER
K923512 · MMK
Sharp-Trap, Inc.
General Hospital · 139d
Cleared Nov 23, 1992
SEIDEL HUMERAL LOCKING NAIL -- ADDITIONAL LENGTHS
K924004 · JDS
Howmedica Corp.
Orthopedic · 105d
Cleared Nov 23, 1992
KINEMATIC MRI MOVIEMAKER
K924154 · LNH
Resonex, Inc.
Radiology · 97d
Cleared Nov 23, 1992
DIGITAL DISK RECORDER W/DUALPATH ARCHIVE/30-60 OPT
K924164 · JAA
Eigen
Radiology · 96d
Cleared Nov 23, 1992
MODIFIED SITE FIBER OPTIC MODULE
K924198 · FCT
Chiron Vision Corp.
Ophthalmic · 95d
Cleared Nov 23, 1992
RADIFOCUS(R) (CATHETER) GUIDE WIRE
K924202 · DQX
Terumo Medical Corp.
Cardiovascular · 95d