Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
139873–139896 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 15, 1987
MMG DELEE SUCTION CATHETER W/MUCOUS TRAP
K871949 · BSY
Medical Technologies of Georgia
Anesthesiology · 26d
Cleared Jun 15, 1987
BEAR JET VENTILATOR FOR USE DURING (ESWL)
K871985 · CBK
Bear Medical Systems, Inc.
Anesthesiology · 24d
Cleared Jun 15, 1987
MODEL TPC-1A OXYGEN ANALYZER
K872001 · CCL
Medical, Inc.
Anesthesiology · 20d
Cleared Jun 15, 1987
MODIFIED (DIRECTIONS FOR USE) FOR IDEIA(TM) TEST
K872056 · LJC
Boots-Celltech Diagnostics, Inc.
Microbiology · 18d
Cleared Jun 15, 1987
CORNING DISPOSABLE ROLLER BOTTLES
K872076 · KJB
Corning Medical & Scientific
Pathology · 17d
Cleared Jun 15, 1987
RAICHEM(TM) SPIA(TM) APO A-1 REAGENTS
K872079 · MSJ
Reagents Applications, Inc.
Immunology · 17d
Cleared Jun 15, 1987
RAICHEM(TM) SPIA(TM) APO B REAGENTS
K872080 · DFC
Reagents Applications, Inc.
Immunology · 17d
Cleared Jun 15, 1987
CIPRO (TM) DIAGNOSTIC POWDER
K872081 · JTT
Miles Pharmaceuticals
Microbiology · 17d
Cleared Jun 15, 1987
ACUSYST-JR
K872086 · KJH
Endotronics, Inc.
Pathology · 14d
Cleared Jun 15, 1987
MCBRIDE MEDIUM CM 819
K872135 · JSJ
Oxoid U.S.A., Inc.
Microbiology · 12d