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
124201–124224 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Nov 13, 1990
HAEMONETICS LN 200F COLLECTION RESERVOIR
K904474 · CAC
Haemonetics Corp.
Anesthesiology · 43d
Cleared Nov 13, 1990
DURAFILL FLOW
K904555 · EBF
Kulzer, Inc.
Dental · 39d
Cleared Nov 13, 1990
KODAK EKTASCAN LASER PRINTER, MODEL 100 XLP
K904590 · LLZ
Eastman Kodak Company
Radiology · 35d
Cleared Nov 09, 1990
SWEDE-VENT ENDOSSEOUS IMPLANT ABUTMENTS
K900182 · DZE
Core-Vent Corp.
Dental · 297d
Cleared Nov 09, 1990
SWEDE-VENT ENDOSSEOUS HA COATED DENTAL IMPLANTS
K900634 · DZE
Core-Vent Corp.
Dental · 273d
Cleared Nov 09, 1990
EXTENDED LIFE CIRCUITS
K903055 · BZO
Pharma Systems, Inc.
Anesthesiology · 121d
Cleared Nov 09, 1990
BACT-HME (TM)
K903058 · BYD
Pharma Systems, Inc.
Anesthesiology · 121d
Cleared Nov 09, 1990
BEST LABS MODEL P
K903471 · ESD
Best Labs
Ear, Nose, Throat · 101d
Cleared Nov 09, 1990
BEST LABS MODEL M
K903472 · ESD
Best Labs
Ear, Nose, Throat · 101d
Cleared Nov 09, 1990
BEST LABS MODEL S
K903473 · ESD
Best Labs
Ear, Nose, Throat · 101d