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
110161–110184 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 21, 1994
AUTO LUBE SYSTEM
K940535 · GEY
The Anspach Effort, Inc.
General & Plastic Surgery · 42d
Cleared Mar 21, 1994
SUREFIRE 12
K940617 · EJT
Argen Precious Metals, Inc.
Dental · 35d
Cleared Mar 21, 1994
AUROLITE 41
K940618 · EJT
Argen Precious Metals, Inc.
Dental · 35d
Cleared Mar 21, 1994
SILFREE 79+
K940619 · EJT
Argen Precious Metals, Inc.
Dental · 35d
Cleared Mar 21, 1994
SILFREE
K940719 · EJT
Argen Precious Metals, Inc.
Dental · 31d
Cleared Mar 18, 1994
HYDRA FITNESS MODEL 311 TOTAL POWER
K926314 · ISD
Henley Intl.
Physical Medicine · 458d
Cleared Mar 18, 1994
HEARTLINE TRANSTELEPHONIC ECG RECEIVING CONSOLE
K930314 · DXH
Aerotel, Ltd.
Cardiovascular · 420d
Cleared Mar 18, 1994
OPHTHALAS 532 SOLID STATE PHOTOCOAGULATOR
K932062 · GEX
Alcon Laboratories
General & Plastic Surgery · 323d
Cleared Mar 18, 1994
BRACE NEUTRALIZER
K932592 · GZJ
Smith and Nephew Donjoy, Inc.
Neurology · 294d
Cleared Mar 18, 1994
DISPOSABLE ARTHROSCOPIC ACCESSORY
K933949 · HRX
United States Surgical, A Division of...
Orthopedic · 218d
Cleared Mar 18, 1994
WATTS RAKE WITH LEUR LOCK PORT
K934153 · GCJ
Phx Technologies Corp.
General & Plastic Surgery · 206d
Cleared Mar 18, 1994
WATTS RAKE WITH LEUR PORT & AQUA-PROBE TIP
K934155 · GCJ
Phx Technologies Corp.
General & Plastic Surgery · 206d
Cleared Mar 18, 1994
VITA CELAY BLANKS AND VITA CELAY OPTIMIZER
K934195 · EIH
Vident
Dental · 204d
Cleared Mar 18, 1994
STRYKER ENDOSCOPIC VIDEO ACCESSORIES
K935234 · GCJ
Stryker Endoscopy
General & Plastic Surgery · 137d
Cleared Mar 18, 1994
CYNOSURE PHOTOTOME SURGICAL DIODE LASER
K935305 · GEX
Cynosure, Inc.
General & Plastic Surgery · 136d
Cleared Mar 18, 1994
REVOLUTION LOWER LIMB CPM UNIT
K935808 · BXB
Toronto Medical, Inc.
Physical Medicine · 106d
Cleared Mar 18, 1994
TREATMENT TABLE MODIFICATION
K936303 · INQ
Tri W-G, Inc.
Physical Medicine · 119d
Cleared Mar 18, 1994
DRESSING CHANGE KIT
K940069 · FYA
Mason-Keller Corp.
General Hospital · 71d
Cleared Mar 18, 1994
CLEO TL80W PROFESSIONAL CLEO TL80W PROFESSIONAL R, CLEO TL100 W PROFESSIONAL
K940672 · LEJ
Philips Lighting Co.
General & Plastic Surgery · 30d
Cleared Mar 18, 1994
TROCAR TUBE
K940688 · GCJ
Phx Technologies Corp.
General & Plastic Surgery · 30d
Cleared Mar 17, 1994
HA TI-FIT ACETABULAR AND FEMORAL COMPONENT
K922621 · MEH
Smith & Nephew Richards, Inc.
Orthopedic · 652d
Cleared Mar 17, 1994
HOLMES AIR PURIFIER MODELS HAP-240 & HAP-300
K925566 · FRF
Holmes Products Corp.
General Hospital · 499d
Cleared Mar 17, 1994
ENDOSCOPIC TRANSMURAL SUTURE NEEDLE SET
K932118 · HET
Core Dynamics, Inc.
Obstetrics & Gynecology · 318d
Cleared Mar 17, 1994
FRANGI-CATH SAFE-RELEASE(TM) CONNECTOR
K932809 · EZL
Excalibur Engineering Care of Rms, Inc.
Gastroenterology & Urology · 281d