FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
29305–29328 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 25, 2017
XO1 Knee Balancing System
K162237 · ONN
Xpandortho, Inc.
Orthopedic · 259d
Cleared Apr 25, 2017
SavDenTM MTA Root Canal Filling Materials
K162661 · KIF
Tyds Biotech Incorporation
Dental · 211d
Cleared Apr 25, 2017
Cliniview
K162799 · LLZ
Palodex Group OY
Radiology · 202d
Cleared Apr 25, 2017
Triton Sponge System
K163507 · PBZ
Gauss Surgical, Inc.,
General & Plastic Surgery · 132d
Cleared Apr 25, 2017
Processor VP-7000, Light Source BL-7000
K163675 · FET
Fujifilm Medical System U.S.A., Inc.
Gastroenterology & Urology · 119d
Cleared Apr 25, 2017
MyoCycle Home, MyoCycle Pro
K170132 · GZI
Myolyn, LLC
Neurology · 98d
Cleared Apr 25, 2017
BC-001+ Acne Purifier
K170260 · OLP
Oriental Inspiration Limited
General & Plastic Surgery · 88d
Cleared Apr 25, 2017
NeoFuse HA Enhanced PLIF/TLIF
K170511 · MAX
Ht Medical, LLC
Orthopedic · 63d
Cleared Apr 25, 2017
Cutera enlighten III Laser System
K170936 · GEX
Cutera, Inc.
General & Plastic Surgery · 26d
Cleared Apr 24, 2017
Apnea Risk Evaluation System (ARES), Model 620
K160499 · MNR
Watermark Medical
Anesthesiology · 426d
Cleared Apr 24, 2017
VX130 Ophthalmic Diagnostic Device
K162067 · HKX
Luneau Sas
Ophthalmic · 272d
Cleared Apr 24, 2017
C-Flex Ureteral Stent Set
K162104 · FAD
Cook Incorporated
Gastroenterology & Urology · 269d
Cleared Apr 24, 2017
Pantheon Medical Balanced Plating System
K162154 · HRS
Pantheon Medical
Orthopedic · 265d
Cleared Apr 24, 2017
PowerPICC Provena Catheters with SOLO Valve Technology
K162441 · LJS
C.R. Bard, Inc.
General Hospital · 236d
Cleared Apr 24, 2017
MindMotionPRO
K162748 · LXJ
Mindmaze SA
Physical Medicine · 206d
Cleared Apr 24, 2017
ORTHOLOC® 3Di Ankle Fusion Plating System Line Extension
K163650 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 122d
Cleared Apr 24, 2017
Foot and Hand Motion
K170012 · HWC
Newclip Technics
Orthopedic · 111d
Cleared Apr 24, 2017
ECG Disposable Lead Wire
K170536 · DSA
APK Technology Co., Ltd.
Cardiovascular · 60d
Cleared Apr 24, 2017
FDR AQRO (DR-XD 1000)
K170858 · IZL
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 33d
Cleared Apr 24, 2017
EVOS Small Fragment Plating System
K170887 · HRS
Smith & Nephew, Inc.
Orthopedic · 28d
Cleared Apr 21, 2017
VivaChek Ino Blood Glucose Monitoring System
K160179 · NBW
Vivachek Laboratories, Inc.
Chemistry · 450d
Cleared Apr 21, 2017
Steri-Cassette and Steri-Cage Sterilization Packaging System
K162063 · KCT
Sybron Dental Specialties
General Hospital · 269d
Cleared Apr 21, 2017
Randox RX Daytona Plus Alkaline Phosphatase (ALP)
K162275 · CJE
Randox Laboratories Limited
Chemistry · 252d
Cleared Apr 21, 2017
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [PURPLE] TESTED...
K162294 · LZA
Brightway Holdings Sdn. Bhd.
General Hospital · 249d