FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
131449–131472 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 24, 1989
AREOLA/NIPPLE DRESSING
K882558 · NAD
Cooper Surgical/Aesthete
General & Plastic Surgery · 337d
Cleared May 24, 1989
IF-II (TM), MODEL 9800
K883462 · LIH
Medical Devices, Inc.
Neurology · 282d
Cleared May 24, 1989
OCTYLDENT
K884652 · EMA
Crx Medical, Inc.
Dental · 198d
Cleared May 24, 1989
ORIENT, LATEX SURGICAL GLOVES, STERILE
K884882 · KGO
Rosa Intl.
General Hospital · 183d
Cleared May 24, 1989
HEALTHSHIELD
K885345 · KPN
Jonas, Inc.
Gastroenterology & Urology · 147d
Cleared May 24, 1989
EVA EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SET
K890094 · KPE
Kells Medical, Inc.
General Hospital · 134d
Cleared May 24, 1989
PVC EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SET
K890095 · KPE
Kells Medical, Inc.
General Hospital · 134d
Cleared May 24, 1989
QUICK-TIP (DENTAL OPERATORY UNIT)
K891006 · EIA
Bernard S Esrock
Dental · 85d
Cleared May 24, 1989
MEDIVERSE PARENTERAL NUTRITION BAG
K891077 · KPE
Mediflex Intl.
General Hospital · 84d
Cleared May 24, 1989
VARIOUSLY SIZED STERILE COTTON WOUND DRESSINGS
K891133 · FRO
Elwyn, Inc.
General & Plastic Surgery · 82d
Cleared May 24, 1989
WEDGE PRESSURE DRESSING
K891189 · FRO
Durden Enterprises, Inc.
General & Plastic Surgery · 79d
Cleared May 24, 1989
LOKSHOT PISTON SYRINGE
K891467 · FMF
Flp Ent., Inc.
General Hospital · 70d
Cleared May 24, 1989
HCG IRMA II
K891770 · JHI
Pacific Biotech, Inc.
Chemistry · 61d
Cleared May 24, 1989
MERIFLUOR(TM) -TRICHOMONAS
K892263 · JWZ
Meridian Diagnostics, Inc.
Microbiology · 50d
Cleared May 24, 1989
AMRESCO URIC ACID REAGENTS #7628
K892395 · KNK
American Research Products Co.
Chemistry · 47d
Cleared May 24, 1989
SR30/SR50/SR60 AUTO SEDIMENT RATE SYSTEM, MODIFIED
K892522 · GKB
Gespac, Inc.
Hematology · 43d
Cleared May 24, 1989
MICROVASIVE ENDOTORQUE GUIDEWIRE, CAT #5177
K892648 · OCY
Boston Scientific Corp
Gastroenterology & Urology · 42d
Cleared May 24, 1989
SDI PREPAX COUNTAPETTE KIT
K892658 · JCG
Scientific Distributors, Inc.
Hematology · 41d
Cleared May 24, 1989
ARGEDENT 87
K892662 · EJT
Argen Precious Metals, Inc.
Dental · 41d
Cleared May 24, 1989
S-FILE, S-FINDER, S-ENGINE FILE
K892894 · EKS
Svenska Dental Instruments AB
Dental · 34d
Cleared May 24, 1989
ARGELITE 60+
K893012 · EJT
Argen Precious Metals, Inc.
Dental · 30d
Cleared May 23, 1989
MRL BLOOD PRESSURE MONITOR
K885191 · DXN
Medical Research Laboratories, Inc.
Cardiovascular · 158d
Cleared May 23, 1989
THE CDI(R) SYSTEM 400
K890113 · DJY
Cardiovascular Devices, Inc.
Toxicology · 132d
Cleared May 23, 1989
ENTERAL BAG/SET
K890151 · KNT
Ashley Health Care, Inc.
Gastroenterology & Urology · 130d