FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
72817–72840 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 03, 2003
BICARBONATE DIALYSATE CONCENTRATE MIXER, MODEL 50 GALLON & 100 GALLON
K022521 · KPO
Rockwell Medical Technologies, Inc.
Gastroenterology & Urology · 157d
Cleared Jan 03, 2003
IMAGE3 SE DISPOSABLE FULL FACE MASK
K023135 · CBK
Respironics, Inc.
Anesthesiology · 105d
Cleared Jan 03, 2003
TROPHYPAN
K023346 · MUH
Trophy Radiologie
Radiology · 88d
Cleared Jan 03, 2003
USA SERIES DUR 8 ELITE, USA SERIES DUR 8, MODELS DUR 8E, DUR 8
K023358 · FGB
Acmi Corporation
Gastroenterology & Urology · 88d
Cleared Jan 03, 2003
ONEPASS NUCLEAR IMAGING SYSTEM, MODEL 70-500101
K023373 · IYX
Gvi Technology Partners
Radiology · 87d
Cleared Jan 03, 2003
IMMUNOCARD STAT! E. COLI O157 PLUS
K023599 · GMZ
Meridian Bioscience, Inc.
Microbiology · 67d
Cleared Jan 03, 2003
CASSETTE/URINE HCG
K023638 · LCX
Ind Diagnostic, Inc.
Chemistry · 65d
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