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
87985–88008 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Oct 05, 1998
OTI MODULAR SHOULDER SYSTEM
K982886 · HSD
Osteoimplant Technology, Inc.
Orthopedic · 49d
Cleared Oct 05, 1998
MVM 7.5 FRENCH FLEXIBLE URETEROSCOPE
K982905 · FGB
Karl Storz Endoscopy
Gastroenterology & Urology · 48d
Cleared Oct 05, 1998
DEPUY C-STEM SYSTEM
K982918 · JDI
DePuy Orthopaedics, Inc.
Orthopedic · 47d
Cleared Oct 05, 1998
QUICKIE SUSPENSION WHEELCHAIR SERIES MODEL XTR
K982989 · IOR
Sunrise Medical, Inc.
Physical Medicine · 40d
Cleared Oct 05, 1998
NON-STERILE KIRSCHNER WIRES AND STEINMANN PINS, MODELS #'S 290-101/160,...
K983121 · HTY
Syntec Scientific Corp.
Orthopedic · 27d
Cleared Oct 02, 1998
AESCULAP SPINE SYSTEM EVOLUTION
K980484 · MNI
Aesculap, Inc.
Orthopedic · 235d
Cleared Oct 02, 1998
HISTOFREEZER DEVICE
K982358 · GEH
OraSure Technologies, Inc.
General & Plastic Surgery · 88d
Cleared Oct 02, 1998
NC-STAT
K982359 · JXE
Neurometrix, Inc.
Neurology · 88d
Cleared Oct 02, 1998
STRYKER HIP ARTHOROSCOPY SET
K982375 · HRX
Stryker Endoscopy
Orthopedic · 87d