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

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176,076 results
73945–73968 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 03, 2003
WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354
K023744 · JHW
Wiener Laboratories Saic
Chemistry · 57d
Cleared Jan 03, 2003
PENTRA 80
K024002 · GKZ
Abx Diagnostics
Hematology · 30d
Cleared Jan 03, 2003
MODIFICATION TO REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTATIVE TEST KIT
K024195 · MID
Corgenix, Inc.
Immunology · 14d
Cleared Jan 03, 2003
REEADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT
K024196 · MID
Corgenix, Inc.
Immunology · 14d
Cleared Jan 03, 2003
LIFEDOP DOPPLER
K024197 · KNG
Summit Doppler Systems, Inc.
Radiology · 14d
Cleared Jan 02, 2003
COSMED MICROQUARK
K020745 · BTY
Cosmed Srl
Anesthesiology · 301d
Cleared Jan 02, 2003
REEVUE INDIRECT CALORIMETER, MODEL#8100
K021490 · BZL
Korr Medical Technologies, Inc.
Anesthesiology · 238d
Cleared Jan 02, 2003
BARD CONFORMEXX BILIARY STENT AND DELIVERY SYSTEM
K021994 · FGE
C.R. Bard, Inc.
Gastroenterology & Urology · 198d
Cleared Jan 02, 2003
CERALAS D 980 LASER SYSTEM WITH ENDO LASER VEIN SYSTEM KIT, MODEL: D15 AND D25
K024088 · GEX
Biolitec, Inc.
General & Plastic Surgery · 22d
Cleared Dec 31, 2002
NIGHTRON POLYSOMNOGRAPHY SYSTEM
K022249 · OLV
Telediagnostic Systems, Inc.
Neurology · 172d
Cleared Dec 31, 2002
PROFILE 1320 LASER SYSTEM
K022466 · GEX
Sciton, Inc
General & Plastic Surgery · 159d
Cleared Dec 31, 2002
BMC CATHETER CONNECTOR CABLE, MODEL RFP-101
K023334 · DSA
Baylis Medical Co., Inc.
Cardiovascular · 85d
Cleared Dec 31, 2002
SOVIS OPTIQUE'S ENDOSCOPIC CABLE
K023633 · FFS
Sovis Optique
Gastroenterology & Urology · 63d
Cleared Dec 31, 2002
ABBOTT PLUM A+ INFUSION PUMP, MODEL 12391
K024084 · FRN
Abbott Laboratories
General Hospital · 20d
Cleared Dec 30, 2002
6.0 X 5.7MM DENTAL IMPLANT
K010185 · DZE
Bicon, Inc.
Dental · 710d
Cleared Dec 30, 2002
THE IZZZY-TENS (WL-2401), THE SLIM-TENS (WL-2402), THE MENS-TENS (WL2403),...
K020020 · GZJ
Well-Life Healthcare, Inc.
Neurology · 361d
Cleared Dec 30, 2002
3I IMPLANTS
K022009 · DZE
Implant Innovations, Inc.
Dental · 194d
Cleared Dec 30, 2002
BALDUR BRAND VINYL POWDER-FREE EXAMINATION GLOVES
K022091 · LYZ
Tangshan Zhonghong Pulin Group Co., Ltd.
General Hospital · 186d
Cleared Dec 30, 2002
CARDIOTECH ANTIBOTIC HYDROGEL WOUND DRESSING
K022584 · MGQ
Cardiotech Intl.
General & Plastic Surgery · 147d
Cleared Dec 30, 2002
ACELL UBM HYDRATED WOUND DRESSING
K022854 · KGN
Acell, Inc.
General & Plastic Surgery · 137d
Cleared Dec 30, 2002
ULTRA-LITE 200E LIGHT CURE UNIT
K023545 · EBZ
Rolence Ent., Inc.
Dental · 69d
Cleared Dec 30, 2002
SICKLE-CHEX SOLUBILITY KIT
K023656 · GHM
Streck Laboratories, Inc.
Hematology · 61d
Cleared Dec 30, 2002
PREPARE ADMINISTRATION SET
K023769 · FPA
Appro Healthcare, Inc.
General Hospital · 48d
Cleared Dec 30, 2002
ATTAIN 6216A-MP MULTI-PURPOSE GUIDE CATHETER FOR LEFT-HEART DELIVERY
K024032 · DQY
Medtronic Vascular
Cardiovascular · 24d