Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
62641–62664 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 02, 2006
ACCESS ULTRASENSITIVE HGH CALIBRATOR, MODEL 33585
K061282 · JIT
Beckman Coulter, Inc.
Chemistry · 25d
Cleared Jun 02, 2006
BARD EXTRA LARGE COMPOSIX KUGEL HERNIA PATCH
K061314 · FTL
Davol Inc., Sub. C. R. Bard, Inc.
General & Plastic Surgery · 22d
Cleared Jun 02, 2006
R&D LH-NRBC HEMATOLOGY CONTROL
K061320 · JPK
R&D Systems, Inc.
Hematology · 22d
Cleared Jun 02, 2006
PORCELAIN PRIMER
K061322 · KLE
J. Morita USA, Inc.
Dental · 22d
Cleared Jun 02, 2006
LC STAR WITH NASAL ADAPTER
K061381 · CAF
Pari Innovative Manufacturers, Inc.
Anesthesiology · 15d
Cleared Jun 01, 2006
MYTIS ARROW XXXX
K052254 · DZE
Brainbase Corporation
Dental · 287d
Cleared Jun 01, 2006
GE LOGIQ 9, MODELS 2188900, 2375600, 2404587 AND 5150000
K061129 · IYN
General Electric Co.
Radiology · 38d
Cleared Jun 01, 2006
CONFLUENT SURGICAL DUAL LIQUID APPLICATOR, MODEL 70-2005-093
K061183 · FMF
Confluent Surgical,Inc
General Hospital · 34d
Cleared Jun 01, 2006
DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
K061189 · IYO
Shenzhen Mindray Bio-Medical...
Radiology · 34d
Cleared May 31, 2006
EYE SEE MULTIPURPOSE, NO-RUB CONTACT LENS SOLUTION
K051104 · LPN
Lapis Lazuli, NV
Ophthalmic · 394d
Cleared May 31, 2006
ANCHOR PLUS/NEO ANCHOR PLUS
K053629 · DZE
Kj Meditech
Dental · 153d
Cleared May 31, 2006
REMA SHAVER BLADES
K060172 · HRX
Rema Medizintechnik GmbH.
Orthopedic · 128d
Cleared May 31, 2006
MICROTEK MEDICAL WARMING DRAPE
K060200 · KKX
Microtek Medical, Inc.
General Hospital · 125d
Cleared May 31, 2006
HEALTH LINE INTERNATIONAL CORPORATIONS,S IV ADMINISTRATIVE SETS
K060352 · FPA
Health Line International Corporation
General Hospital · 107d
Cleared May 31, 2006
JUNIPER COOLING DEVICE
K060407 · GEX
Juniper Medical Technology, Inc.
General & Plastic Surgery · 104d
Cleared May 31, 2006
AESCULAP BIPOLAR ACETABULAR CUP
K060707 · KWY
Aesculap, Inc.
Orthopedic · 76d
Cleared May 31, 2006
IRIDEX OTOPROBE LONG AND SHORT ANGLES, P/N 14310-1 AND 14320-1
K060905 · GEX
Iridex Corp
General & Plastic Surgery · 58d
Cleared May 31, 2006
ACCUTECH ENDOLITE PROBE
K061025 · FFS
Accutech Medical Technologies, Inc.
Gastroenterology & Urology · 48d
Cleared May 31, 2006
AUTO SUTUR ENDO GIA STAPLERS
K061095 · GDW
United States Surgical, A Division of...
General & Plastic Surgery · 42d
Cleared May 31, 2006
ORAL B PROFESSIONALCARE SERIES, ORAL B ADVANCEPOWER SERIES
K061199 · JEQ
Braun GmbH
Dental · 33d
Cleared May 31, 2006
DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR
K061251 · JIS
Dade Behring, Inc.
Chemistry · 27d
Cleared May 31, 2006
REFLECTION 3 ACETABULAR SYSTEM
K061253 · MBL
Smith & Nephew, Inc.
Orthopedic · 27d
Cleared May 31, 2006
INSPIRSTAR GLOVE ELECTRODE
K061343 · GXY
Inspirstar, Inc.
Neurology · 16d
Cleared May 30, 2006
DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES,...
K053363 · GYC
Ad-Tech Medical Instrument Corp
Neurology · 179d