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
86857–86880 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 11, 1999
ZOLL M SERIES SPO2 OPTION
K982992 · MKJ
Zoll Medical Corp
Cardiovascular · 196d
Cleared Mar 11, 1999
CONSTELLATION MULTIPLE ELECTRODE PACING AND RECORDING SYSTEM
K983171 · MTD
Boston Scientific Corp
Cardiovascular · 182d
Cleared Mar 11, 1999
GT1 FLOPPY, GT1 HI-PER FLEX, GT1 LIGHT SUPPORT
K983927 · DQT
Arterial Vascular Engineering, Inc.
Cardiovascular · 126d
Cleared Mar 11, 1999
UNIVERSAL ADJUSTABLE T-RAIL TABLE BRACKET
K984418 · DXT
Medrad, Inc.
Cardiovascular · 91d
Cleared Mar 11, 1999
ELECTROGLOTTOGRAPH
K990240 · KLX
Kay Elemetrics Corp.
Ear, Nose, Throat · 45d
Cleared Mar 11, 1999
MABIS NB-02 ULTRASONIC NEBULIZER
K990506 · CAF
Mabis Healthcare, Inc.
Anesthesiology · 22d
Cleared Mar 11, 1999
ESTECH ARTERIAL REMOTE ACCESS PERFUSION CANNULA
K990573 · DXC
Estech, Inc.
Cardiovascular · 16d
Cleared Mar 10, 1999
TITANIUM FEMORAL COMPONENT
K981996 · JWH
Biomet, Inc.
Orthopedic · 275d
Cleared Mar 10, 1999
MODIFICATION OF THE ZPLATE-ATL ANTERIOR FIXATION SYSTEM
K990603 · KWQ
Danek Medical, Inc.
Orthopedic · 15d
Cleared Mar 09, 1999
WAKO AUTOKIT LP(A)
K981446 · DFC
Wako Chemicals USA, Inc.
Chemistry · 321d
Cleared Mar 09, 1999
WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHISPERFLOW...
K982283 · BYE
Caradyne, Ltd.
Anesthesiology · 252d
Cleared Mar 09, 1999
GTI-PF4 ELISA
K983379 · LCO
Genetic Testing Institute
Hematology · 165d
Cleared Mar 09, 1999
MODIFICATION OF MAXIMA FORTE' HOLLOW FIBER OXYGENATOR WITH BALANCE...
K984271 · DTZ
Medtronic Vascular
Cardiovascular · 99d
Cleared Mar 09, 1999
SYSTEM U3 FOR CEFUROXIME
K984491 · JWY
Ab Biodisk
Microbiology · 82d
Cleared Mar 09, 1999
SYSTEM U3 FOR CEPHALOTHIN
K984581 · JWY
Ab Biodisk
Microbiology · 76d
Cleared Mar 09, 1999
GENTAMICIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K984608 · JTN
Oxoid , Ltd.
Microbiology · 71d
Cleared Mar 09, 1999
LC FLOWFILL
K990108 · EBF
S & C Polymer GmbH
Dental · 55d
Cleared Mar 09, 1999
ABBOTT LIQUID ASSAYED CHEMISTRY CONTROL, MODEL 1E81-01/1E82-01
K990282 · JJY
Bio-Rad
Chemistry · 39d
Cleared Mar 09, 1999
BLUE POWDER-FREE NITRILE EXAMINATION GLOVES
K990283 · LZA
Hartalega Sdn Bhd
General Hospital · 39d
Cleared Mar 09, 1999
DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, DMF 25
K990375 · IKT
Medtronic Functional Diagnostics A/S
Neurology · 29d
Cleared Mar 09, 1999
NITRILE EXAMINATION GLOVES, POWDER FREE, GREEN COLOR
K990453 · LZA
Alliance Rubber Products Sdn. Bhd.
General Hospital · 25d
Cleared Mar 09, 1999
MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VR
K990514 · DTP
C.R. Bard, Inc.
Cardiovascular · 19d
Cleared Mar 09, 1999
OSOM CARD PREGNANCY TEST, MODEL 103
K990576 · LCX
Wyntek Diagnostics, Inc.
Chemistry · 14d
Cleared Mar 09, 1999
OSOM CARD II HCG-URINE TEST, MODEL 102
K990578 · JHI
Wyntek Diagnostics, Inc.
Chemistry · 14d