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
109873–109896 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 18, 1994
GOOSEN SELF-LUBRICATING CATHETER
K923848 · EZD
Goosen Enterprises, Inc.
Gastroenterology & Urology · 567d
Cleared Feb 18, 1994
LAPROSCOPIC/ENDOSCOPIC SURGICAL INSTRUMENTS
K925499 · GCJ
Lapsurg of America
General & Plastic Surgery · 476d
Cleared Feb 18, 1994
AD/V A.5
K925799 · LMA
Adaptive Video, Inc.
Radiology · 459d
Cleared Feb 18, 1994
CANNULA: KAHN, JARCO, CORSON AND RATCHET
K930038 · LKF
Thomasville Medical Assoc.
Obstetrics & Gynecology · 409d
Cleared Feb 18, 1994
OTOACOUSTIC EMISSIONS UNIT CELESTA 503
K931325 · EWO
Madsen Electronics (Canada) , Ltd.
Ear, Nose, Throat · 339d
Cleared Feb 18, 1994
NOVUS IMAGE ARCHIVE SYSTEM, TELERADIOLOGY SYSTEM
K931410 · LMB
Novus Technologies, Inc.
Radiology · 336d
Cleared Feb 18, 1994
MEDISYSTEMS APHERESIS NEEDLE WITH GUARD
K932074 · FIE
Medisystems Corp.
Gastroenterology & Urology · 296d
Cleared Feb 18, 1994
CRYSTAL VISION AND ACCESSORIES
K932230 · FYD
I.C Medical, Inc.
General Hospital · 287d
Cleared Feb 18, 1994
SMT-100X/H AND SMT-100X/X MAGNETIC RESONANCE IMAGING SYSTEM
K932244 · LNH
Shimadzu Medical Systems
Radiology · 284d
Cleared Feb 18, 1994
CEMAX CLINICALVIEW(TM) STATION AND/OR SOFTWARE
K932371 · LLZ
Cemax, Inc.
Radiology · 280d
Cleared Feb 18, 1994
APEX SPX CARDIAL
K932673 · IYX
Elscint, Inc.
Radiology · 261d
Cleared Feb 18, 1994
MRT-50GP
K933018 · LNH
Toshiba America Mri, Inc.
Radiology · 241d
Cleared Feb 18, 1994
COGENT LIGHT ILLUMINATOR 10010 XENON LIGHT SOURCE
K933405 · GCT
Cogent Light Technologies, Inc.
Gastroenterology & Urology · 221d
Cleared Feb 18, 1994
CONMED ECG PATIENT CABLES AND LEADWIRES
K933649 · DSA
Conmedcorp
Cardiovascular · 206d
Cleared Feb 18, 1994
STRYKER LAPAROSCOPIC SUCTION IRRIGATOR
K934094 · GCJ
Stryker Corp.
General & Plastic Surgery · 179d
Cleared Feb 18, 1994
MECTRA TROCAR
K934547 · GCJ
Mectra Labs, Inc.
General & Plastic Surgery · 149d
Cleared Feb 18, 1994
CHLORIDE (MF) ASSAY
K934588 · CHG
Diagnostic Chemicals , Ltd.
Chemistry · 148d
Cleared Feb 18, 1994
R2+
K934758 · EJH
Jeneric/Pentron, Inc.
Dental · 137d
Cleared Feb 18, 1994
CARBON FIBER PALLET
K934766 · IYX
Siemens Gammasonics, Inc.
Radiology · 137d
Cleared Feb 18, 1994
GX-770 X-RAY CONTROL, MODEL 46-404600G4
K935046 · EHD
Gendex Corp.
Radiology · 121d
Cleared Feb 18, 1994
JEDMED COMPACT ENDOSCOPIC BEAMSPLITTER
K935247 · FEA
Jedmed Instrument Co.
Gastroenterology & Urology · 109d
Cleared Feb 18, 1994
K-LOK CATHETER SECUREMENT DEVICE MODIFICATION
K935252 · KMK
K-Lok, Inc.
General Hospital · 134d
Cleared Feb 18, 1994
QUANTAPHASE II B12/FOLATE
K935286 · CGN
Bio-Rad
Chemistry · 137d
Cleared Feb 18, 1994
STRYKER AMBULANCE COT MODEL 6060
K935297 · FPO
Stryker Medical
General Hospital · 108d