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
139273–139296 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 16, 1987
MODEL 617 CARDIAC OUTPUT COMPUTER
K870375 · DXG
Omnimed B.V.
Cardiovascular · 138d
Cleared Jun 16, 1987
DYNATRON 438
K870515 · IPF
Henley Intl.
Physical Medicine · 131d
Cleared Jun 16, 1987
GUIDING CATHETERS 9F JL4
K871021 · DQO
Devices For Vascular Intervention, Inc.
Cardiovascular · 92d
Cleared Jun 16, 1987
ALLEVYN HYDROPHILIC POLYURETHANE DRESSING
K871166 · NAD
Smith & Nephew, Inc.
General & Plastic Surgery · 84d
Cleared Jun 16, 1987
RESUB. URINE COCAINE META. DIRECT RIA KIT [I-125]
K871549 · KLN
Immunalysis Corporation
Chemistry · 63d
Cleared Jun 16, 1987
OVER DRAPE LEG HOLDER
K871900 · KQZ
Avec Scientific Design Corp.
Orthopedic · 32d
Cleared Jun 16, 1987
FRASTEC DRY BURN DRESSING
K871916 · EFQ
Fraass Survival Systems, Inc.
General & Plastic Surgery · 29d
Cleared Jun 16, 1987
FRASTEC DRY GAUZE BANDAGE
K871917 · EFQ
Fraass Survival Systems, Inc.
General & Plastic Surgery · 29d
Cleared Jun 15, 1987
SP55 SYRINGE PUMP
K870330 · FRN
Vickers , Ltd.
General Hospital · 138d
Cleared Jun 15, 1987
SENSIR SYSTEM
K870719 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 115d
Cleared Jun 15, 1987
EXTENSION TUBE PUMP SET
K871085 · FPK
Churchill Corp.
General Hospital · 89d
Cleared Jun 15, 1987
IV PUMP SET
K871086 · FPA
Churchill Corp.
General Hospital · 89d
Cleared Jun 15, 1987
MASSTRON/MARQUEST MT-1000 GAS ANALYZER
K871253 · CCK
Masstron C/O Burditt, Bowles &...
Anesthesiology · 77d
Cleared Jun 15, 1987
MULTIPLE PHARMA-PLAST TRACHEAL TUBE
K871263 · BTR
Pharma-Plast USA, Inc.
Anesthesiology · 76d
Cleared Jun 15, 1987
MECONIUM ASPIRATOR
K871407 · BSY
Intertech Resources, Inc.
Anesthesiology · 68d
Cleared Jun 15, 1987
IONESCU-SHILEY PERICARDIAL XENOGRAFT (ISU)
K871596 · DTJ
Shiley, Inc.
Cardiovascular · 52d
Cleared Jun 15, 1987
WH150 ROOM HUMIDIFIER
K871661 · KFZ
Associated Mills, Inc.
Anesthesiology · 48d
Cleared Jun 15, 1987
NASOPHARYNGEAL AIRWAY
K871673 · BTQ
Harding Industries, Inc.
Anesthesiology · 48d
Cleared Jun 15, 1987
RESUBMISSION OF URINE HEROIN/MORPHINE KIT [I-125]
K871698 · DJG
Immunalysis Corporation
Chemistry · 48d
Cleared Jun 15, 1987
CHURCHILL-H VENTED IV SET W/METERING CHAMBERS
K871732 · FPA
Churchill Corp.
General Hospital · 41d
Cleared Jun 15, 1987
MODIFIED USE OF PLEX INSPIRATORY MUSCLE TRAINER
K871742 · BWF
Health Products, Inc.
Anesthesiology · 41d
Cleared Jun 15, 1987
SIEMENS DRY AIR COMPRESSOR
K871829 · BTI
Siemens Elema AB
Anesthesiology · 35d
Cleared Jun 15, 1987
TINA-QUANT [A] CRP
K871895 · DCK
Boehringer Mannheim Corp.
Immunology · 31d
Cleared Jun 15, 1987
TINA-QUANT [A] TRANSFERRIN
K871896 · DDG
Boehringer Mannheim Corp.
Immunology · 31d