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
123601–123624 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 13, 1990
DENTAL CLEANING RINGS
K902325 · JES
H. Bernath & Assoc.
Dental · 173d
Cleared Nov 13, 1990
CRANIOTOME BLADE OR DRILL BIT
K902703 · HBE
A. Henniss
Neurology · 146d
Cleared Nov 13, 1990
STERILE I.V. START KIT
K902810 · FPA
Orion Life Systems, Inc.
General Hospital · 139d
Cleared Nov 13, 1990
DEVICE PART NUMBER SVD2, 3, 4 SPADE DRILL
K902929 · DZE
Minimatic Implant Technology
Dental · 133d
Cleared Nov 13, 1990
DEVICE PART NUMBER: PD-12 PILOT DRILL
K902931 · DZE
Minimatic Implant Technology
Dental · 131d
Cleared Nov 13, 1990
G.E. POLARIX II C-ARM
K902982 · JAA
Electromek Diagnostic Systems, Inc.
Radiology · 140d
Cleared Nov 13, 1990
AA-1110 ANALOG ABUTMENT
K903042 · DZE
Minimatic Implant Technology
Dental · 125d
Cleared Nov 13, 1990
HS-1113 HEALING SCREW - REV. A
K903062 · DZE
Minimatic Implant Technology
Dental · 127d
Cleared Nov 13, 1990
PART NUMBER: TA-1118 TAP
K903112 · DZE
Minimatic Implant Technology
Dental · 123d
Cleared Nov 13, 1990
PP-1105 PARALLEL PIN
K903114 · DZE
Minimatic Implant Technology
Dental · 123d
Cleared Nov 13, 1990
DG-1109 DEPTH GAGE
K903115 · DZE
Minimatic Implant Technology
Dental · 123d
Cleared Nov 13, 1990
BO-1121 BALL OVERDENTURE ATTACHMENT
K903516 · DZE
Minimatic Implant Technology
Dental · 102d
Cleared Nov 13, 1990
AIB-1120 ANALOG-IMPLANT BODY
K903517 · DZE
Minimatic Implant Technology
Dental · 102d
Cleared Nov 13, 1990
CAREKITS(TM), IV/CATH/CENT LINE DRESS/TPN/CVP KITS
K903545 · FOZ
J.J. Skinner, Inc.
General Hospital · 99d
Cleared Nov 13, 1990
EF SYNERGY QUAD
K903589 · JWY
Remel Co.
Microbiology · 97d
Cleared Nov 13, 1990
BRUKER R-28,HEAD AND CHEST ANGIOGRAPHY IMAGING ADD
K903661 · LNH
Bruker Medical Imaging, Inc.
Radiology · 92d
Cleared Nov 13, 1990
HAEMONETICS CELL SAVER 4 PLUS
K904041 · CAC
Haemonetics Corp.
Anesthesiology · 70d
Cleared Nov 13, 1990
RAICHEM (TM) SPIA (TM) - ACID GLYCOPROTEIN REAGENT
K904175 · LKL
Reagents Applications, Inc.
Immunology · 63d
Cleared Nov 13, 1990
R-800-SF
K904182 · ITY
Advantech
Radiology · 63d
Cleared Nov 13, 1990
ACCUPROBE STREPTOCOCCUS PYOGENES CULTURE CONFIRM.
K904268 · MDK
Gen-Probe, Inc.
Microbiology · 56d
Cleared Nov 13, 1990
ST-4 COAGULATION INSTRUMENT
K904297 · GKP
American Bioproducts Co.
Hematology · 55d
Cleared Nov 13, 1990
MULTI FORMAT VIDEO IMAGER 600 PLUS
K904363 · LMC
International Imaging Electronics
Radiology · 50d
Cleared Nov 13, 1990
TEC 1410
K904397 · IZO
Bay Shore Medical Equipment Corp.
Radiology · 49d
Cleared Nov 13, 1990
ACCUPROBE MYCOBACTERIUM KANSASII CULT CONFIRM TEST
K904463 · LQF
Gen-Probe, Inc.
Microbiology · 43d