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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
81961–81984 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 23, 2000
HME-BOOSTER
K990614 · BTT
King Systems Corp.
Anesthesiology · 453d
Cleared May 23, 2000
NDD MEDICAL TECHNOLOGIES EASYONE SPIROMETER: FRONTLINE MODEL 2000 AND...
K993921 · BZG
Ndd Medical Technologies
Anesthesiology · 187d
Cleared May 23, 2000
VINYL PATIENT EXAMINATION GLOVES-POWDER FREE
K994098 · LYZ
Evergreen Medical Produts (Jingxing)...
General Hospital · 172d
Cleared May 23, 2000
NEER III TOTAL SHOULDER SYSTEM
K994350 · KWS
Smith & Nephew, Inc.
Orthopedic · 152d
Cleared May 23, 2000
GLOVETEX, LATEX EXAMINATION GLOVES, POWDERED NON-STERILE.(PROTEIN CONTENT...
K994426 · LYY
Pt. Wrp Buana Multicorpora
General Hospital · 145d
Cleared May 22, 2000
ETEST GATIFLOXACIN
K000596 · JWY
Ab Biodisk
Microbiology · 90d
Cleared May 22, 2000
THE APTUS (AUTOMATED) APPLICATION OF THE TG IGG ELISA TEST SYSTEM. AN ENZYME...
K000879 · LJM
Zeus Scientific, Inc.
Immunology · 63d
Cleared May 22, 2000
THE APTUS (AUTOMATED APPLICATION OF THE TPO IGG ELISA TEST SYSTEM. AN ENZYME...
K000880 · LJM
Zeus Scientific, Inc.
Immunology · 63d
Cleared May 22, 2000
GATIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K000930 · JTN
Oxoid , Ltd.
Microbiology · 61d
Cleared May 22, 2000
MULTISAFE POWDER-FREE PATIENT LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT...
K000999 · LYY
Multisafe Sdn. Bhd.
General Hospital · 55d
Cleared May 22, 2000
NYCOCARD HBA1C GLYCOSYLATED HEMOGLOBIN ASSAY
K993131 · LCP
Primus, Inc.
Hematology · 245d
Cleared May 22, 2000
VIDAS TOXO IGG II (TXG) ASSAY MODEL 30 210
K993319 · LGD
bioMerieux, Inc.
Microbiology · 231d
Cleared May 22, 2000
SPORTSIGHT GP
K993586 · HQD
Paragon Vision Sciences
Ophthalmic · 213d
Cleared May 19, 2000
MENICON Z
K000133 · HQD
Menicon U.S.A., Inc.
Ophthalmic · 122d
Cleared May 19, 2000
MENICON SF-P
K000233 · HQD
Menicon Co, Ltd.
Ophthalmic · 113d
Cleared May 19, 2000
WALLSTENT BILIARY ENDOPROSTHESIS
K000308 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 108d
Cleared May 19, 2000
CUSTOMCORNEA MEASUREMENT DEVICE (CCMD)
K000637 · NCF
Alcon Laboratories, Inc.
Ophthalmic · 84d
Cleared May 19, 2000
DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS)
K000704 · GBX
Dmc Medical, Ltd.
General & Plastic Surgery · 78d
Cleared May 19, 2000
HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND...
K000723 · KOD
Rochester Medical Corp.
Gastroenterology & Urology · 74d
Cleared May 19, 2000
ARROW ULTRA 8 INTRA-AORTIC BALLOON CATHETERS (IABS) 8FR 30CC AND 40CC UNIVERSAL
K000729 · DSP
Arrow Intl., Inc.
Cardiovascular · 74d
Cleared May 19, 2000
SOFTFORM FACIAL IMPLANT
K000849 · FTL
Tissue Technologies, Inc.
General & Plastic Surgery · 65d
Cleared May 19, 2000
C&B RESIN PLUS POWDER/LIQUID, MODELS RETEMP A2, A3, A3.5, CL, RETEMP B2, B3,...
K000894 · EBG
Dental Ventures of America, Inc.
Dental · 60d
Cleared May 19, 2000
KAWASUMI LABORATORY BLOOD DRAWING KIT
K001043 · KSB
Kawasumi Laboratories America, Inc.
Hematology · 49d
Cleared May 19, 2000
POLYMACON
K001089 · LPL
CooperVision, Inc.
Ophthalmic · 45d