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
62905–62928 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 04, 2006
CARBON DIOXIDE
K060295 · KHS
Abbott Laboratories
Chemistry · 87d
Cleared May 04, 2006
STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TEST PAK, CALPAK, DILPAK
K060369 · NQD
Dade Behring, Inc.
Chemistry · 80d
Cleared May 04, 2006
AUTOMOBILE LIGHTER POWER CORD
K060549 · CBK
Pulmonetic Systems, Inc.
Anesthesiology · 63d
Cleared May 04, 2006
RC LOOP /DUAL ORTHOCORD SUTURE,RC LOOP W/ETHIBOND SUTURE,RC LOOP W/PANACRYL...
K060553 · JDR
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 64d
Cleared May 04, 2006
KVUE IGRT TREATMENT TABLE TOP, RT-4551KV, KVUE INSERTS AND ACCESSORIES, VARIOUS
K060671 · JAI
Wfr/Aquaplast Corp.
Radiology · 51d
Cleared May 04, 2006
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K060884 · LYZ
Wei Fang Jiuzhou Gloves Co., Ltd.
General Hospital · 34d
Cleared May 04, 2006
POWDERED VINYL PATIENT EXAMINATION GLOVES
K060886 · LYZ
Wei Fang Jiuzhou Gloves Co., Ltd.
General Hospital · 34d
Cleared May 04, 2006
INSURE II
K060930 · KHE
Enterix, Inc.
Hematology · 29d
Cleared May 04, 2006
DP-6600 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
K060949 · IYO
Shenzhen Mindray Bio-Medical...
Radiology · 28d
Cleared May 04, 2006
G-SCAN-MODEL 9800020000, E-SCAN MODEL 9800010000 AND E-SCAN...
K060956 · LNH
Esaote, S.P.A.
Radiology · 27d
Cleared May 04, 2006
BABYBEAT CORDLESS
K061091 · KNG
The Newman Group, LLC
Radiology · 15d
Cleared May 03, 2006
GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS WITH PROXIMAL CEMENT SPACER
K052639 · JDI
Biomet Manufacturing, Inc.
Orthopedic · 219d
Cleared May 03, 2006
SENSOR WALK
K052771 · IQI
Otto Bock Healthcare LP
Physical Medicine · 215d
Cleared May 03, 2006
PIEZOTOME
K060275 · ELC
Satelec
Dental · 90d
Cleared May 03, 2006
DRILLTECH, ISM, IMPLANTUNIT, ZIMMER SURGICAL MOTOR SYSTEM
K060287 · EBW
W&H Dentalwerk Buermoos GmbH
Dental · 86d
Cleared May 03, 2006
ACRO RAPID PHENCYCLIDINE URINE TEST, CATALOG PCP001000
K060353 · LCM
Acro Biotech, LLC
Toxicology · 79d
Cleared May 03, 2006
TOTAL BILIRUBIN
K060574 · CIG
Abbott Laboratories
Chemistry · 58d
Cleared May 03, 2006
ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH
K060585 · CKG
Roche Diagnostics Corp.
Chemistry · 57d
Cleared May 03, 2006
LEGION COBALT CHROME REVISION KNEE SYSTEM
K060742 · JWH
Smith & Nephew, Inc.
Orthopedic · 44d
Cleared May 03, 2006
SPY INTRAOPERATIVE IMAGING SYSTEM
K060867 · IZI
Novadaq Technologies, Inc.
Radiology · 34d
Cleared May 03, 2006
GE LOGIQ P5 AND A5
K060993 · IYN
General Electric Co.
Radiology · 22d
Cleared May 03, 2006
EG-3670URK
K061068 · ODG
Pentax Medical Company
Radiology · 16d
Cleared May 03, 2006
SPEECHLINK 100 TYPE 1053
K061104 · ETW
Gn Otometrics A/S
Ear, Nose, Throat · 13d
Cleared May 02, 2006
KIMBERLY-CLARK PROCEDURE GOWN
K052824 · FYA
Kimberly-Clark Corp.
General Hospital · 209d