FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
83161–83184 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 20, 2000
DOUBLE SPRINGERS
K993735 · HIS
Medtech Products , Ltd.
Obstetrics & Gynecology · 137d
Cleared Mar 20, 2000
MIGHTY MAN (DYNAMIC LINKERS)
K993737 · HIS
Medtech Products , Ltd.
Obstetrics & Gynecology · 137d
Cleared Mar 20, 2000
BARD ENDOSCOPIC SUTURING SYSTEM
K994290 · ODE
C.R. Bard, Inc.
Gastroenterology & Urology · 90d
Cleared Mar 20, 2000
REVERSO
K994306 · KOC
Medisystems Corp.
Gastroenterology & Urology · 90d
Cleared Mar 20, 2000
MODULAP
K994319 · GEI
Atc Technologies, Inc.
General & Plastic Surgery · 89d
Cleared Mar 20, 2000
PROSOFT (PHEMFILCON) SOFT (HYDROPHILIC) CONTACT LENS
K994335 · LPL
Wesley Jessen Corp.
Ophthalmic · 88d
Cleared Mar 17, 2000
ELECSYS B-CROSSLAPS CALCHECK
K000042 · JJX
Roche Diagnostics Corp.
Chemistry · 71d
Cleared Mar 17, 2000
STERIS AMSCO MILLENNIUM STEAM STERILIZER
K000077 · FLE
STERIS Corporation
General Hospital · 66d
Cleared Mar 17, 2000
PORTSETT
K000085 · FMI
Portsett, Inc.
General Hospital · 65d
Cleared Mar 17, 2000
MARHUKAR TRIPLE LUMEN CATHETER, MODEL 12 FR
K000087 · FOZ
The Kendal Co.
General Hospital · 65d
Cleared Mar 17, 2000
BUILD-IT FR
K000211 · EBF
Jeneric/Pentron, Inc.
Dental · 53d
Cleared Mar 17, 2000
BRAHMS DIAGNOSTICA LUMITEST ANTI-TG
K000286 · JZO
Brahms Diagnostica, LLC
Immunology · 46d
Cleared Mar 17, 2000
BRAHMS DIAGNOSTICA LUMITEST ANTI-TPO
K000287 · JZO
Brahms Diagnostica, LLC
Immunology · 46d
Cleared Mar 17, 2000
VARELISA SM ANTIBODIES
K000312 · LKP
Pharmacia & Upjohn Co.
Immunology · 45d
Cleared Mar 17, 2000
EBT ULTRAFAST CT SCANNER SYSTEM
K000359 · JAK
Imatron, Inc.
Radiology · 42d
Cleared Mar 17, 2000
CONVERTORS EQUIPMENT DRAPES
K000417 · KKX
Allegiance Healthcare Corp.
General Hospital · 38d
Cleared Mar 17, 2000
ELECTROSURGICAL GENERATOR, MODEL S1
K000501 · GEI
Somnus Medical Technologies, Inc.
General & Plastic Surgery · 31d
Cleared Mar 17, 2000
OTW MEGALINK SDS BILIARY STENT SYSTEM
K000550 · FGE
Advanced Cardiovascular Systems, Inc.
Gastroenterology & Urology · 28d
Cleared Mar 17, 2000
FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
K000583 · CGA
Selfcare, Inc.
Chemistry · 24d
Cleared Mar 17, 2000
SUPERGLOVES STERILE POWDERED LATEX EXAMINATION GLOVES
K000644 · LYY
Supermax Glove Manufacturing Sdn Bhd
General Hospital · 21d
Cleared Mar 17, 2000
CO2-OP-PNEU COMPUTER, WISAP #7050C, #7050CF, #7050CMF
K992481 · HET
Wisap Gesellschaft Fur Wissenschaftl....
Obstetrics & Gynecology · 235d
Cleared Mar 17, 2000
THERME-PNEU COMPUTER, WISAP #7070C, #7070CF, #7070CM, #7070CMF
K992513 · HET
Wisap Gesellschaft Fur Wissenschaftl....
Obstetrics & Gynecology · 235d
Cleared Mar 17, 2000
SOLOGUARD LOCKING PLUS SYRINGE
K993609 · MEG
Safeguard Medical Products, Inc.
General Hospital · 144d
Cleared Mar 17, 2000
SYNOCTA ANGLED ABUTMENTS
K994119 · DZE
Straumann USA
Dental · 102d