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
91657–91680 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 26, 1997
BELZER-MPS
K972066 · KDN
Trans-Med Corp.
Gastroenterology & Urology · 176d
Cleared Nov 26, 1997
NIPRO BLOOD TUBING SET WITH TRANSDUCER AND SOLUTION SET FOR HEMODIALYSIS
K972206 · KOC
Nipro Medical Corp.
Gastroenterology & Urology · 168d
Cleared Nov 26, 1997
AURENORM 68
K972945 · EJS
Aurex Precious Metal Industries (Pty)Ltd
Dental · 159d
Cleared Nov 26, 1997
DICOM 3.0 SOFTWARE VERSION 2.0
K973239 · LMD
Adac Laboratories
Radiology · 90d
Cleared Nov 26, 1997
ENDOASSIST
K973249 · GCJ
Armstrong Healthcare , Ltd.
General & Plastic Surgery · 89d
Cleared Nov 26, 1997
MICROAIRE POWER ASPIRATION DEVICE PAD SYSTEM
K973268 · BTA
Microaire Surgical Instruments, Inc.
General & Plastic Surgery · 89d
Cleared Nov 26, 1997
BIOPOLAR BUTTON ELECTRODE, WL 150MM, W/SUCTION APPLICATOR/WL 280MM, W/SUCTION...
K973295 · GEI
Richard Wolf Medical Instruments Corp.
General & Plastic Surgery · 85d
Cleared Nov 26, 1997
PIN CARE KIT
K973299 · EFQ
Brown Medical Industries
General & Plastic Surgery · 85d
Cleared Nov 26, 1997
COBRA HAND PIECE
K973366 · KNS
Vidamed, Inc.
Gastroenterology & Urology · 79d
Cleared Nov 26, 1997
AUROFILM 2000
K973372 · EJT
Metalor Dental USA Corp.
Dental · 79d
Cleared Nov 26, 1997
STERI-OSS 3.25 MM REPLACE DENTAL IMPLANT SYSTEM
K973402 · DZE
Steri-Oss, Inc.
Dental · 78d
Cleared Nov 26, 1997
TRANSDUCER POSITIONER
K973622 · ITX
Protek Medical Products, Inc.
Radiology · 64d
Cleared Nov 26, 1997
ENDOCERVICAL BLOCK NEEDLE
K973671 · HEE
A & A Medical, Inc.
Obstetrics & Gynecology · 61d
Cleared Nov 26, 1997
PERSONAL LUBRICATING LIQUID
K973780 · HIS
Qualis, Inc.
Obstetrics & Gynecology · 54d
Cleared Nov 26, 1997
CARDS Q.S. HCG SERUM/URINE
K973858 · JHI
Quidel Corp.
Chemistry · 48d
Cleared Nov 26, 1997
SERUM HCG CONTROL SET (NEGATIVE, LOW POSITIVE AND HIGH POSITIVE)
K974108 · JJX
Quidel Corp.
Chemistry · 26d
Cleared Nov 25, 1997
ENDOSCOPIC HYSTERECTOMY AND UTERUS MANIPULATOR
K964276 · HEW
Richard Wolf Medical Instruments Corp.
Obstetrics & Gynecology · 393d
Cleared Nov 25, 1997
TRITEST REAGENT CD3 FITC/CD16+CD56 PE/CD45 PERCP
K971110 · GKZ
Becton Dickinson Immunocytometry Systems
Hematology · 244d
Cleared Nov 25, 1997
WHITTINGHAM ULTRACLEAN PHACO HANDPIECE
K972063 · HQC
William F. Whittingham
Ophthalmic · 175d
Cleared Nov 25, 1997
RHEUMACOL RHEUMATOID FACTOR TEST
K972456 · DHR
Immunostics Inc.,
Immunology · 147d
Cleared Nov 25, 1997
FAVC-HH: FEMORAL ARTERY VASCULAR CLAMP-HAND HELD: 1/2 & 3 POUNDS...
K973216 · DXC
Rmds, Inc.
Cardiovascular · 90d
Cleared Nov 25, 1997
STING SKIN PREP WIPE(59420600)/STING SKIN PREP SWAB (59420700)
K973228 · KMF
Smith & Nephew, Inc.
General & Plastic Surgery · 90d
Cleared Nov 25, 1997
D.O.R.C. HEXON ILLUMINATION SYSTEM
K973229 · MPA
Dutch Ophthalmic USA, Inc.
Ophthalmic · 90d
Cleared Nov 25, 1997
MONARCH (IN 2125)/INTELLISYSTEM (IN 1125)
K973230 · DXT
Merit Medical Systems, Inc.
Cardiovascular · 90d