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
160753–160776 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 25, 1982
DISPERSED PHASE ALLOY
K820617 · EJJ
Goldsmith & Revere, Inc.
Dental · 17d
Cleared Mar 25, 1982
CORNING 902 SODIUM POTASSIUM ANALYZER
K820629 · CFM
Corning Medical & Scientific
Chemistry · 17d
Cleared Mar 25, 1982
COLORIMETRIC URIC ACID REAGENT SET
K820632 · KNK
Biorent Diagnostic, Inc.
Chemistry · 17d
Cleared Mar 25, 1982
CATH-HOLD
K820637 · KOD
Womco Products
Gastroenterology & Urology · 17d
Cleared Mar 25, 1982
ATRAC TM MULTIPURPOSE BALLOON CATHETER
K820646 · DXE
Atrium Medical Corp.
Cardiovascular · 16d
Cleared Mar 25, 1982
OPTICATH
K820674 · DQE
Oximetrix, Inc.
Cardiovascular · 14d
Cleared Mar 25, 1982
TOUCH FLUSH W/Y TRANSDUCER CONNECTOR
K820676 · DRS
Norton Performance Plastics Corp.
Cardiovascular · 14d
Cleared Mar 25, 1982
TOUCH FLUSH CONTINUOUS FAST/FLUSH
K820677 · DRS
Norton Performance Plastics Corp.
Cardiovascular · 14d
Cleared Mar 25, 1982
AUTO SECTOR MCU
K827036
Technicare Corp.
Radiology · 87d
Cleared Mar 23, 1982
COMPUDIAL/KP-1
K813107 · LIF
Computer Dialysis Systems, Inc.
Gastroenterology & Urology · 140d
Cleared Mar 23, 1982
SORB II
K813574 · FKT
Organon Teknika Corp.
Gastroenterology & Urology · 90d
Cleared Mar 23, 1982
CRUCIATE LIGAMENT BUTTON
K813581 · KGS
Biomet, Inc.
General & Plastic Surgery · 85d
Cleared Mar 23, 1982
COBE CENTRY 2000 RX
K820125
Cobe Laboratories, Inc.
Gastroenterology & Urology · 64d
Cleared Mar 23, 1982
UNI-SET
K820128 · BZO
Inhalation Therapy Equipment, Co.
Anesthesiology · 64d
Cleared Mar 23, 1982
DISA WATER CYSTOMETER
K820144 · FAP
Disa Electronics
Gastroenterology & Urology · 63d
Cleared Mar 23, 1982
COBE SINGLE-NEEDLE CONTROLLER #18-756
K820173 · FIF
Cobe Laboratories, Inc.
Gastroenterology & Urology · 61d
Cleared Mar 23, 1982
IMPROVED DYCAL
K820215 · EJK
Dentsply Intl.
Dental · 56d
Cleared Mar 23, 1982
HYDROGEN PEROXIDE TOPICAL
K820221 · LIF
Renal Systems, Inc.
Gastroenterology & Urology · 55d
Cleared Mar 23, 1982
RNG SERIES ULTRASOUND NEEDLE/CATH. GDS
K820269 · DWO
CIVCO Medical Instruments Co., Inc.
General & Plastic Surgery · 49d
Cleared Mar 23, 1982
BOSTON SYRINGE
K820294 · FMF
Frisco Products, Inc.
General Hospital · 48d
Cleared Mar 23, 1982
AM. PH. STERILE SINGLE-USE URETHRAL CATH
K820419 · KOD
American Pharmaseal Div. Ahsc
Gastroenterology & Urology · 35d
Cleared Mar 23, 1982
AM. PH. STERILE FEEDING TUBE
K820420 · KNT
American Pharmaseal Div. Ahsc
Gastroenterology & Urology · 35d
Cleared Mar 23, 1982
HOLLISTER ODOR ABSORBING WOUND PAD
K820464 · NAB
Hollister, Inc.
General & Plastic Surgery · 29d
Cleared Mar 23, 1982
MGC/LITTON 2300
K820475 · BZL
Medical Graphics Corp.
Anesthesiology · 32d