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
113617–113640 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 16, 1993
IGA SUBCLASS RID KIT FOR DIAGNOSTIC USE
K931806 · CZP
The Binding Site, Ltd.
Immunology · 95d
Cleared Jul 16, 1993
HEMAGEN CARDIOLIPIN ANTIBODY KIT (EIA METHOD0
K932373 · MID
Hemagen Diagnostics, Inc.
Immunology · 60d
Cleared Jul 16, 1993
PRECISION MED PRODUCTS, LTD. BREATHING BAGS
K932496 · BTC
Precision Med Products, Ltd.
Anesthesiology · 52d
Cleared Jul 16, 1993
MAPLESON D CIRCUITS
K932559 · CAI
Life Shield Healthcare Products, Inc.
Anesthesiology · 50d
Cleared Jul 16, 1993
VENTILATOR HOSES
K932563 · BZO
Life Shield Healthcare Products, Inc.
Anesthesiology · 50d
Cleared Jul 16, 1993
COAXIAL CIRCUITS
K932579 · CAI
Med-Plastics Intl., Inc.
Anesthesiology · 50d
Cleared Jul 16, 1993
PEDIATRIC ANESTHESIA CIRCUITS
K932580 · CAI
Med-Plastics Intl., Inc.
Anesthesiology · 50d
Cleared Jul 16, 1993
BREATHING BAGS
K932581 · BTC
Med-Plastics Intl., Inc.
Anesthesiology · 50d
Cleared Jul 16, 1993
CUSTOM ANESTHESIA CIRCUITS
K932582 · CAI
Med-Plastics Intl., Inc.
Anesthesiology · 50d
Cleared Jul 16, 1993
BREATHING BAGS
K932584 · BTC
Merit Medical Systems, Inc.
Anesthesiology · 50d
Cleared Jul 16, 1993
PEDIATRIC ANESTHESIA CIRCUITS
K932585 · CAI
Merit Medical Systems, Inc.
Anesthesiology · 50d
Cleared Jul 16, 1993
CUSTOM ANESTHESIA CIRCUITS
K932586 · CAI
Merit Medical Systems, Inc.
Anesthesiology · 50d
Cleared Jul 16, 1993
COAXIAL CIRCUITS
K932587 · CAI
Merit Medical Systems, Inc.
Anesthesiology · 50d
Cleared Jul 14, 1993
VINYL ADDITION SILICONE SYSTEM
K926150 · ESD
Crown Delta Corp.
Ear, Nose, Throat · 219d
Cleared Jul 14, 1993
ABBOTT ENCOUNTER(TM)Q
K930309 · GKZ
Abbott Laboratories
Hematology · 174d
Cleared Jul 14, 1993
BLOOD GAS KIT (NON-STERILE) REORDER NO. 0560
K930986 · CBT
Customed, Inc.
Anesthesiology · 139d
Cleared Jul 14, 1993
DUKAL SKIN CLOSURE STRIP
K931005 · FPX
Dukal Corp.
General & Plastic Surgery · 138d
Cleared Jul 14, 1993
PSG DIRECTIONAL HYDROPHILIC GUIDE WIRE
K931327 · DQX
Peripheral Systems Group
Cardiovascular · 120d
Cleared Jul 14, 1993
ARGELITE 85
K931554 · EJT
Argen Precious Metals, Inc.
Dental · 106d
Cleared Jul 14, 1993
ALPHA II
K931725 · EHD
Dynarad Corp.
Radiology · 100d
Cleared Jul 14, 1993
BELTONE OPERA/OPERA MHP/OPERA MAX
K932426 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 56d
Cleared Jul 14, 1993
PMP, LTD. CUSTOM ANESTHESIA CIRCUITS
K932490 · CAI
Precision Med Products, Ltd.
Anesthesiology · 51d
Cleared Jul 14, 1993
TDX(R)/TDX(R)FLX(R)MEHTOTREXATE II
K932615 · LAO
Abbott Laboratories
Toxicology · 43d
Cleared Jul 13, 1993
FPC/SFPC/RFPC ACETABULAR COMPONENT
K915529 · JDL
Implantology Corp.
Orthopedic · 581d