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
121417–121440 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 23, 1991
REMEDI(TM) DRUG PROFILING SYSTEM, MODIFICATION
K911954 · DJR
Bio-Rad
Toxicology · 22d
Cleared May 22, 1991
SPIROSIFT 500A
K904200 · BZG
Fukuda Denshi USA, Inc.
Anesthesiology · 252d
Cleared May 22, 1991
SERIES 7000 CARBON DIOXIDE MODULE
K904789 · CCK
Marquette Electronics, Inc.
Anesthesiology · 211d
Cleared May 22, 1991
CARDIOPULMONARY BYPASS PUMP TUBING
K910021 · DWF
Jtl Medical Corp.
Cardiovascular · 139d
Cleared May 22, 1991
ACTH IRMA KIT MITSUBISHI YUKA
K910178 · CKG
Science Regulatory Services Intl.
Chemistry · 127d
Cleared May 22, 1991
NEBU-SOL METERED DOSE DISPENSER (TM)
K910239 · BSY
Dey Laboratories, Inc.
Anesthesiology · 120d
Cleared May 22, 1991
SITE 20 GAUGE REUSABLE FIBER OPTIC CABLE
K910980 · HJO
Site Microsurgical Systems, Inc.
Ophthalmic · 76d
Cleared May 22, 1991
QUALITATIVE KERATOMETER M823 WITH POWER SUPPLY
K911062 · HNO
Storz Instrument Co.
Ophthalmic · 72d
Cleared May 22, 1991
OSMOMETER MODEL 2400
K911092 · JJM
Advanced Instruments, Inc.
Chemistry · 72d
Cleared May 22, 1991
HDL CHOLESTEROL REAGENT
K911406 · LBR
Genzyme Corp.
Chemistry · 54d
Cleared May 22, 1991
MILENIA PROGESTERONE
K911512 · JLS
Diagnostic Products Corp.
Chemistry · 48d
Cleared May 22, 1991
CATHCAP, CAT. NO. CC100 SERIES
K911519 · DQY
Gish Biomedical, Inc.
Cardiovascular · 48d
Cleared May 22, 1991
ACA(R) URINE DRUGS OF ABUSE CONTROL, MODIFICATION
K911724 · DIF
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 35d
Cleared May 22, 1991
CONTROL FOR PH,BLOOD GASES,ELETROLYTES,GLUCOSE
K911755 · JJY
Bionostics, Inc.
Chemistry · 34d
Cleared May 22, 1991
SUNGLASSES-NONPRESCRIPTION INCLUDING PHOTOSEN.
K911766 · HQY
Gall'S, Inc.
Ophthalmic · 33d
Cleared May 21, 1991
WHEELCHAIR CONVERSION KIT
K904650 · ITI
Hadco Marketing Services, Inc.
Physical Medicine · 231d
Cleared May 21, 1991
AUTOMASTER
K904934 · IPQ
Team Mfg., Inc.
Physical Medicine · 201d
Cleared May 21, 1991
S-ROM OBLONG ACETABULAR CUP
K905258 · JDI
Joint Medical Products Corp.
Orthopedic · 181d
Cleared May 21, 1991
HALE SUN SURGICAL TOWEL OR O.R. TOWEL
K905803 · KKX
Hale Sun Industries, Ltd.
General Hospital · 144d
Cleared May 21, 1991
TARGET ASO TEST
K910073 · GTQ
Texas Immunology, Inc.
Microbiology · 132d
Cleared May 21, 1991
WALLACH COLD SOAKER
K910491 · GEH
Wallach Surgical Devices, Inc.
General & Plastic Surgery · 105d
Cleared May 21, 1991
RICH-MAR MODEL X ULTRASOUND THERAPY DEVICE
K910708 · IMI
Rich-Mar Corp.
Physical Medicine · 90d
Cleared May 21, 1991
VILLAN (VIDEO LIFT LINK ANALYSIS)
K910712 · LXI
Physio Systems, Inc.
Orthopedic · 90d
Cleared May 21, 1991
JACKSON MULTIPURPOSE OPERATING TABLE
K910736 · JEA
Orthopedic Systems, Inc.
General & Plastic Surgery · 89d