FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
88489–88512 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 06, 1998
QT DISPERSION AND T WAVE ANALYSIS PROGRAM (QT GUARD ANALYSIS SYSTEM)
K981024 · LOS
Marquette Medical Systems, Inc.
Cardiovascular · 201d
Cleared Oct 06, 1998
DIGITAL RADIOGRAPHIC IMAGING SYSTEM
K982196 · KPR
GE Medical Systems
Radiology · 106d
Cleared Oct 06, 1998
TRIAGE,PARASITE PANEL, TRIAGE CRYPTOSPORIDIUM AND ENTAMOEBA HISTOLYTICA,...
K982245 · MHI
Biosite Incorporated
Microbiology · 102d
Cleared Oct 06, 1998
E.CAM EXTRA HIGH ENERGY COLLIMATOR
K982387 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 89d
Cleared Oct 06, 1998
7250 ULTRASOUND IMAGING SYSTEM
K982444 · IYO
Biosound Esaote, Inc.
Radiology · 84d
Cleared Oct 06, 1998
ULTRAPRO MODEL 98
K982563 · LLZ
Ramsoft, Inc.
Radiology · 75d
Cleared Oct 06, 1998
DELTON FS DIRECT DELIVERY SYSTEM
K982564 · EBC
Dentsply Intl.
Dental · 75d
Cleared Oct 06, 1998
PHILIPS TOMOSCAN CS
K982631 · JAK
Philips Medical Systems, Inc.
Radiology · 70d
Cleared Oct 06, 1998
TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSION
K982683 · EPF
Telex Communications, Inc.
Ear, Nose, Throat · 67d
Cleared Oct 06, 1998
BARCO MEDICAL DISPLAY CONFORMITY AND CONSISTENCY SOFTWARE
K982690 · LLZ
Barco N.V.
Radiology · 64d
Cleared Oct 06, 1998
MODEL 545G-64 PAHASED ARRAY MUSCULOSKELETAL FLEX COIL PACKAGE MODEL 543GE-64:...
K983109 · MOS
Medical Advances, Inc.
Radiology · 32d
Cleared Oct 06, 1998
MICROFUSE DUAL RATE INFUSER
K983321 · FRN
Baxa Corp.
General Hospital · 14d
Cleared Oct 05, 1998
VMT SYSTEM
K971549 · LXV
Target Health, Inc.
Ear, Nose, Throat · 525d
Cleared Oct 05, 1998
ULTIMA AIRFLOW SENSOR, 0510
K981445 · BZQ
Braebon Medical Corp.
Anesthesiology · 166d
Cleared Oct 05, 1998
ACTION STORM RANGER II, ACTION STORM POWER 9000
K982064 · ITI
Invacare Corp.
Physical Medicine · 115d
Cleared Oct 05, 1998
MOMENTUM NO. FS008 WHEELCHAIR
K982099 · IOR
Sriram Enterprises D.B.A. Momentum Group
Physical Medicine · 112d
Cleared Oct 05, 1998
RFG-3C PLUS
K982489 · GXD
Radionics, Inc.
Neurology · 80d
Cleared Oct 05, 1998
TENOR SPINAL SYSTEM
K982490 · KWP
Sofamor Danek USA,Inc.
Orthopedic · 80d
Cleared Oct 05, 1998
BROWSER (EVENT SOFTWARE) MODEL # 4500E
K982550 · BZQ
Respironics, Inc.
Anesthesiology · 75d
Cleared Oct 05, 1998
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TXL
K982583 · JAK
Shimadzu Corp.
Radiology · 73d
Cleared Oct 05, 1998
DEPUY AMK TOTAL KNEE SYSTEM DEPUY COORDINATE ULTRA KNEE REVISION SYSTEM
K982585 · JWH
DePuy Orthopaedics, Inc.
Orthopedic · 73d
Cleared Oct 05, 1998
OLYMPUS MH-246R BALLOON SHEATH, FOR URINARY TRACT USE
K982734 · ODG
The Olympus Optical Co.
Radiology · 61d
Cleared Oct 05, 1998
VAIL 1000 ENCLOSED BED
K982783 · FNL
Vail Products, Inc.
General Hospital · 59d
Cleared Oct 05, 1998
PANTHER WHEELCHAIR
K982849 · IOR
Snug Seat, Inc.
Physical Medicine · 54d