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
160489–160512 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 21, 1982
RPMI-164POWDERED MEDIUM
K820929 · KIT
Dutchland Laboratories, Inc.
Microbiology · 20d
Cleared Apr 21, 1982
FISCHER'S POWDERED MEDIUM
K820930 · KIT
Dutchland Laboratories, Inc.
Microbiology · 20d
Cleared Apr 21, 1982
HANK'S 199 POWDERED MEDIUM
K820931 · KIT
Dutchland Laboratories, Inc.
Microbiology · 20d
Cleared Apr 21, 1982
PATIENT PAL I.V. WALKER
K820963 · FOX
Pryor Products
General Hospital · 15d
Cleared Apr 21, 1982
BATHTUB GRAB BAR
K821009 · ILS
Guardian Products Co., Inc.
Physical Medicine · 9d
Cleared Apr 21, 1982
BATHTUB TRANSFER BENCH
K821010 · IKX
Guardian Products Co., Inc.
Physical Medicine · 9d
Cleared Apr 21, 1982
LIGHT WEIGHT ALUMINUM CANES
K821402 · IPS
Manuco Manufacturing Co., Inc.
Physical Medicine
Cleared Apr 21, 1982
MODEL SSD-119
K827284
Aloka Co., Ltd.
Radiology · 22d
Cleared Apr 21, 1982
MODEL SSD-710
K827285
Aloka Co., Ltd.
Radiology · 22d
Cleared Apr 21, 1982
MLX LATERAL IMAGING SYSTEM
K827288
General Electric Co.
Radiology · 22d
Cleared Apr 21, 1982
DIGITAL RADIOGRAPHY SYSTEM
K827289
Diagnostic Technology, Inc.
Radiology · 22d
Cleared Apr 20, 1982
COTTON SWABS
K820962 · KXF
Dafoe & Dafoe, Inc.
General Hospital · 14d
Cleared Apr 19, 1982
ORX DENT-AIDE DENTAL EMERGENCY KIT
K820501
Dental Aide Products
Dental · 53d
Cleared Apr 16, 1982
RODDER VOLUME VENTILATOR
K820248 · CBK
Pharmaquest Corp.
Anesthesiology · 77d
Cleared Apr 16, 1982
SUCTION CATHETERS & KITS
K820369 · BSY
American Pharmaseal Div. Ahsc
Anesthesiology · 66d
Cleared Apr 16, 1982
NASAL OXYGEN CATHETER
K820370 · BZB
American Pharmaseal Div. Ahsc
Anesthesiology · 66d
Cleared Apr 16, 1982
PHONOTRACE 2000
K820452 · DXH
Lowrance Electronics, Inc.
Cardiovascular · 57d
Cleared Apr 16, 1982
IMPLANTIBLE SUTURE SLEEVE
K820487 · DTB
Intermedics, Inc.
Cardiovascular · 52d
Cleared Apr 16, 1982
FITC ANTI-RABIES MONOCLONAL GLOBULIN
K820499 · GOI
Centocor, Inc.
Microbiology · 52d
Cleared Apr 16, 1982
NEWPORT VENTILATOR MODEL E100
K820746 · CBK
Newport Medical Instruments, Inc.
Anesthesiology · 28d
Cleared Apr 16, 1982
LH RADIOIMMUNOASSAY TEST SYSTEM
K820760 · CEP
Monobind
Chemistry · 25d
Cleared Apr 16, 1982
GAMBRO LUNDIA 10 3N PARALLEL FLOW DIAL
K820769 · FKQ
Gambro, Inc.
Gastroenterology & Urology · 25d
Cleared Apr 16, 1982
CULTURE MEDIA, SINGLE BIOCHEM. TEST
K820839 · JSF
Blue Ridge Media Co.
Microbiology · 21d
Cleared Apr 16, 1982
CULTURE MEDIA, GENERAL NUTRIENT BROTH
K820840 · JSC
Blue Ridge Media Co.
Microbiology · 21d