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
87457–87480 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 24, 1998
PHILIPS BUCKY VISION
K982795 · MQB
Philips Medical Systems, Inc.
Radiology · 106d
Cleared Nov 24, 1998
FLOWMATE II PLUS, MODEL #4000
K982956 · BZG
Spirometrics Medical Equipment Co.
Anesthesiology · 92d
Cleared Nov 24, 1998
ULTRASOUND WORKSTATION, UIWS-300A
K982976 · LLZ
Toshiba America Medical Systems, In.C
Radiology · 90d
Cleared Nov 24, 1998
TUBING BLOOD FLOW METER MODEL NUMBER HD-800
K982986 · DPW
Koven Technology, Inc.
Radiology · 90d
Cleared Nov 24, 1998
IN-PROBE II URODYNAMIC SYSTEM
K983325 · FEN
Influence, Inc.
Gastroenterology & Urology · 63d
Cleared Nov 24, 1998
INTERGARD KNITTED ULTRA THIN COLLAGEN COATED VASCULAR GRAFT AND HEMACAROTID...
K983819 · DSY
Intervascular, Inc.
Cardiovascular · 26d
Cleared Nov 24, 1998
DISTAFLO BYPASS GRAFT
K983861 · DSY
Impra, Inc.
Cardiovascular · 22d
Cleared Nov 24, 1998
ARCHITECT TSH MASTERCHECK, LIST NO, 6C52-05
K984072 · JJX
Bio-Rad
Chemistry · 8d
Cleared Nov 23, 1998
METERED DOSE INHALER-REUSABLE MODEL NUMBER RTC 21-A, METERED DOSE...
K981249 · CAF
Instrumentation Industries, Inc.
Anesthesiology · 231d
Cleared Nov 23, 1998
AURORA
K981379 · GEX
Premier Laser Systems, Inc.
General & Plastic Surgery · 221d
Cleared Nov 23, 1998
M1145 (UPS1-1.25K-1G-MP) UPS
K981412 · CBK
Clary Corp.
Anesthesiology · 217d
Cleared Nov 23, 1998
STEALTHSTATION TREATMENT GUIDANCE PLATFORM
K981768 · HAW
Surgical Navigation Technologies, Inc.
Neurology · 188d
Cleared Nov 23, 1998
SD TRANS-OSSEOUS FASTENER MODELS TOB 6 BOLT 32/50, TOB 6 BOLT 50/80, TOB 6...
K982354 · HTN
Special Devices, Inc.
Orthopedic · 140d
Cleared Nov 23, 1998
ENDOCAM CAMERA SYSTEMS 5502/5507 WITH CR CAMERA HEADS AND ACCESSORIES
K982965 · FWF
Richard Wolf Medical Instruments Corp.
General & Plastic Surgery · 90d
Cleared Nov 23, 1998
ORATEC TAC-C, MONOPOLAR CAUTERY PROBE
K982971 · GEI
Oratec Interventions, Inc.
General & Plastic Surgery · 90d
Cleared Nov 23, 1998
MODEL 340GE-21C QUADRATURE BRAIN COIL
K982978 · MOS
Medical Advances, Inc.
Radiology · 90d
Cleared Nov 23, 1998
OSTEO 5.0MM CANNULATED SCREW SYSTEM
K983006 · HWC
Stryker Osteonics
Orthopedic · 87d
Cleared Nov 23, 1998
CUSTOM FLANGED ACETABULAR COMPONENT
K983035 · LPH
Biomet, Inc.
Orthopedic · 84d
Cleared Nov 23, 1998
BPOS-IVAD STABILIZER
K983480 · LJT
Bpos, Inc.
General Hospital · 52d
Cleared Nov 23, 1998
QUADRANT ANTERIOR SHINE
K983549 · EBF
Cavex Holland BV
Dental · 45d
Cleared Nov 23, 1998
SPECTRUM SPIRIT
K983763 · IOR
Freedom Designs, Inc.
Physical Medicine · 28d
Cleared Nov 23, 1998
MITEK FASTIN RC ANCHOR
K983818 · MBI
Mitek Products
Orthopedic · 25d
Cleared Nov 23, 1998
V-CATH PICC (PERIPHERALLY INSERTED CENTRAL CATHETER)
K983916 · FOZ
Hdc Corp.
General Hospital · 20d
Cleared Nov 20, 1998
URESIL VASCU-FLO INFUSION CATHETER
K980278 · DQY
Uresil Corp.
Cardiovascular · 298d