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
85321–85344 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 20, 1999
DELTON FS WITH FLUORIDE PIT & FISSURE SEALANT
K991909 · EBC
Dentsply Intl.
Dental · 74d
Cleared Aug 20, 1999
INTRAVASCULAR ADMINISTRATION SET
K991932 · FPA
The Kipp Group
General Hospital · 73d
Cleared Aug 20, 1999
COOK HIGH VOLUME INFUSION ADAPTER INTRAVASCULAR ADMINISTRATION SET
K991985 · FPA
Cook, Inc.
General Hospital · 67d
Cleared Aug 20, 1999
CHOLESITE TEST SYSTEM
K992132 · CHH
Gds Technology, LLC
Chemistry · 58d
Cleared Aug 20, 1999
LACTOSORB SHEETS
K992158 · JEY
Biomet, Inc.
Dental · 56d
Cleared Aug 20, 1999
PALL SURGICLEAR LAPAROSCOPIC SMOKE FILTRATION SYSTEM, MODEL CLSF1
K992361 · FYD
Pall Medical
General Hospital · 36d
Cleared Aug 20, 1999
ADVANTA GRAFT
K992441 · DYF
Atrium Medical Corp.
Cardiovascular · 29d
Cleared Aug 20, 1999
ADVANTA GRAFT
K992443 · DSY
Atrium Medical Corp.
Cardiovascular · 29d
Cleared Aug 20, 1999
BLULAZE
K992620 · GEX
Premier Laser Systems, Inc.
General & Plastic Surgery · 15d
Cleared Aug 19, 1999
POCKIT HSV 2 RAPID TEST
K983886 · LGC
Diagnology , Ltd.
Microbiology · 290d
Cleared Aug 19, 1999
JOSTRA HL-20 TWIN PUMP
K984338 · DPW
Jostra Bentley
Cardiovascular · 259d
Cleared Aug 19, 1999
ELECTRO-NERVE STIMULATOR TENS, MODEL LX
K990230 · GZJ
Biomedical Life Systems, Inc.
Neurology · 206d
Cleared Aug 19, 1999
SAS ADENO TEST
K990630 · GOD
Sa Scientific, Inc.
Microbiology · 174d
Cleared Aug 19, 1999
TILT/RECLINER FOR POWER WHEELCHAIRS, MODEL 2G
K991119 · ITI
Invacare Corp.
Physical Medicine · 139d
Cleared Aug 19, 1999
LDL CHOLESTEROL, PRODUCT NO'S, 124-01, CH102-01
K991664 · LBS
A.P. Total Care, Inc.
Chemistry · 97d
Cleared Aug 19, 1999
MAC SERIES ELECTROCARDIOGRAPHS INCLUDING MAC 5000, MAC PC, MAC 6, MAC VU, MAC...
K991735 · LOS
General Electric Medical Systems...
Cardiovascular · 90d
Cleared Aug 19, 1999
COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR
K991739 · HGM
General Electric Medical Systems...
Obstetrics & Gynecology · 90d
Cleared Aug 19, 1999
MAGNATEK 30
K991819 · DQA
Magna Advanced Technologies, Inc.
Anesthesiology · 84d
Cleared Aug 19, 1999
STREP B OIA
K991828 · GTY
Biostar, Inc.
Microbiology · 83d
Cleared Aug 19, 1999
TRUSTEX MINT FLAVORED CONDOM IN GREEN COLOR, IMPULSE MINT FLAVORED CONDOM IN...
K991892 · HIS
Line One Laboratories
Obstetrics & Gynecology · 77d
Cleared Aug 19, 1999
EBI XFIX DFS RAIL SYSTEM
K991941 · KTT
Electro-Biology, Inc.
Orthopedic · 71d
Cleared Aug 19, 1999
ACRY ISLAND BORDER DRESSING, MODELS 2031, 2032, 2033
K992032 · KMF
Acrymed, Inc.
General & Plastic Surgery · 64d
Cleared Aug 19, 1999
VARIOUS ANSELL TRADENAMES OR PRIVATE LABEL
K992081 · HIS
Suretex Prophylactics (India) , Ltd.
Obstetrics & Gynecology · 59d
Cleared Aug 19, 1999
OLYMPUS SERUM PROTEIN MULTICALIBRATOR 2
K992086 · JIX
Olympus America, Inc.
Toxicology · 59d