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
130849–130872 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 25, 1989
PATIENT EXAMINATION GLOVES
K892462 · LYY
Hollymount Trading & Mfg.
General Hospital · 48d
Cleared May 25, 1989
MAYTEX PATIENT EXAMINATION GLOVES
K892553 · LYY
American Seal Co.
General Hospital · 45d
Cleared May 25, 1989
STERILE PATIENT EXAMINATION GLOVE
K892554 · LYY
Shun Thai Rubber Gloves Industry Co.,...
General Hospital · 45d
Cleared May 25, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892567 · LYY
Anhui Light Industrial Products I/E...
General Hospital · 45d
Cleared May 25, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892683 · LYY
Vollrath Group, Inc.
General Hospital · 44d
Cleared May 25, 1989
PATIENT EXAM GLOVES (MFG. POLYMINT INDUSTRIAL CO.)
K892686 · LYY
Intl. Visco Group
General Hospital · 44d
Cleared May 25, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892742 · LYY
Shen Wei (Usa), Inc.
General Hospital · 44d
Cleared May 25, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892761 · LYY
E-Full Industrial , Ltd.
General Hospital · 44d
Cleared May 25, 1989
PLASTER CUTTING SCISSORS
K892823 · LRW
The South India Surgical Co. Pvt. , Ltd.
General & Plastic Surgery · 44d
Cleared May 25, 1989
FLEX-CUP PERCUSSOR
K892862 · BYI
Life Design Systems, Inc.
Anesthesiology · 37d
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