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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
134329–134352 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 12, 1988
FORTIFY
K882915 · EBF
Bisco, Inc.
Dental · 31d
Cleared Aug 12, 1988
IDS RAPID ANA SYSTEM
K882960 · JSP
Innovative Diagnostic Systems, Inc.
Microbiology · 29d
Cleared Aug 12, 1988
PALLIAG NF III
K883036 · EJT
Degussa Dental, Inc.
Dental · 24d
Cleared Aug 11, 1988
AMBUL. PH & MOTILITY RECORDER FOR MEASURE OF PARA.
K880581 · FFX
Synectics-Dantec
Gastroenterology & Urology · 183d
Cleared Aug 11, 1988
MIC NEEDLE JEJUNOSTOMY TUBE KIT
K880767 · KNT
Medical Innovations Corp.
Gastroenterology & Urology · 167d
Cleared Aug 11, 1988
DPS-33,000 WITH CENTOR OPTION
K881017 · LLZ
Adac Laboratories
Radiology · 154d
Cleared Aug 11, 1988
FIRST AMERICAN, RADIONIC, JKR, MODEL AC
K881480 · ESD
Jkr Laboratories, Inc.
Ear, Nose, Throat · 128d
Cleared Aug 11, 1988
PLEURAL BIOPSY PUNCH NEEDLE
K881624 · GDM
E.G. Dick & Assoc.
General & Plastic Surgery · 121d
Cleared Aug 11, 1988
OMNITRON REMOTE CONTROLLED RADIONUCLIDE APPLICATOR
K881665 · JAQ
Omnitron Intl., Inc.
Radiology · 115d
Cleared Aug 11, 1988
SELF ADHESIVE URINARY EXTERNAL CATH. W/REMOVE. TIP
K881678 · KNX
Hollister, Inc.
Gastroenterology & Urology · 114d
Cleared Aug 11, 1988
INDICATENS 4X4
K881708 · GZJ
Acudata Software
Neurology · 113d
Cleared Aug 11, 1988
SURGITEK CO2 DELIVERY SYSTEM
K881736 · FAP
Medical Engineering Corp.
Gastroenterology & Urology · 111d
Cleared Aug 11, 1988
MODEL 90DX MULTITEST METER
K882032 · FLB
Mesa Medical, Inc.
Gastroenterology & Urology · 87d
Cleared Aug 11, 1988
ENTRUST(TM) MODEL 800
K882047 · FRN
Avi, Inc.
General Hospital · 87d
Cleared Aug 11, 1988
PERFUSOR M SYRINGE PUMP
K882106 · FRN
Burron Medical, Inc.
General Hospital · 85d
Cleared Aug 11, 1988
PERFUSOR SECURA SYRINGE PUMP
K882107 · FRN
Burron Medical, Inc.
General Hospital · 84d
Cleared Aug 11, 1988
CENTRIX TRI-LAMINATE POST SYSTEM
K882125 · ELR
Centrix, Inc.
Dental · 83d
Cleared Aug 11, 1988
INTERSEPT* OXYGEN GAS LINE FILTER
K882136 · KRD
Medtronic Blood Systems, Inc.
Cardiovascular · 83d
Cleared Aug 11, 1988
VTR-12
K882176 · JAA
Eigen
Radiology · 79d
Cleared Aug 11, 1988
VIEWPOINT
K882205 · LLZ
Adac Laboratories
Radiology · 77d
Cleared Aug 11, 1988
IMPRINT VINYL POLYSILOXANE IMPRESSION MATERIAL
K882690 · ELW
3M Company
Dental · 42d
Cleared Aug 10, 1988
LASERMATIC SURGILASER MODEL 5050
K870587 · EWG
Lasermatic OY
Ear, Nose, Throat · 547d
Cleared Aug 10, 1988
LAMINARIA CUREX
K881295 · HDY
Harold W. Berger Co.
Obstetrics & Gynecology · 135d
Cleared Aug 10, 1988
KIMGUARD (REGULAR & HEAVY DUTY) STERILE WRAP
K881471 · FRG
Kimberly-Clark Corp.
General Hospital · 125d