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
91153–91176 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Nov 25, 1997
IMAGE FUSION AND REVIEW SYSTEM
K973233 · KPS
Adac Laboratories
Radiology · 89d
Cleared Nov 25, 1997
LEG'MAP OPTION
K973270 · IZI
Ge Medical Systems, Inc.
Radiology · 84d
Cleared Nov 25, 1997
IMATION MODEL 9410 NETWORK INTERFACE
K973303 · LMD
Imation Corp.
Radiology · 83d
Cleared Nov 25, 1997
ARTICULATE FITTING SYSTEM
K973320 · EWO
Decibel Instruments, Inc.
Ear, Nose, Throat · 83d
Cleared Nov 25, 1997
ID. STORE (RELEASE 2.0)
K973413 · LMB
I.S.G. Technologies, Inc.
Radiology · 77d
Cleared Nov 25, 1997
MEDENTAL CHEMICAL CURING SEALANT PIT & FISSURE TINTED
K973541 · EBC
Medental Intl.
Dental · 68d
Cleared Nov 25, 1997
ABBOTT AXSYM TROPONIN-I
K974103 · MMI
Abbott Laboratories
Chemistry · 25d
Cleared Nov 24, 1997
PSN-120 HOLLOW FIBER DIALYZER AND PSN-140 HOLLOW FIBER DIALYZER
K963933 · FJI
Baxter Healthcare Corp
Gastroenterology & Urology · 419d
Cleared Nov 24, 1997
VERY PRIVATE INTIMATE MOISTURE
K971793 · HIS
Brandwynne Corp.
Obstetrics & Gynecology · 193d