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
136633–136656 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 30, 1988
TSA W/LEC. & TWEEN. 80
K880142 · JSG
Hardy Media
Microbiology · 84d
Cleared Mar 30, 1988
TRUST RPR TEST FOR SYPHILIS IN SERUM OR PLASMA
K880165 · GMQ
Ampcor, Inc.
Microbiology · 77d
Cleared Mar 30, 1988
RPR TEST FOR SYPHILIS IN SERUM OR PLASMA
K880477 · GMQ
Ampcor, Inc.
Microbiology · 55d
Cleared Mar 30, 1988
KALLESTAD QM300 CALIBRATOR C PACK
K880729 · DCK
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 36d
Cleared Mar 30, 1988
CAMPLYOBACTER CULTURE MEDIA PRODUCTS P3873/T3597
K880945 · JSJ
Lakewood Biochemical Co., Inc.
Microbiology · 23d
Cleared Mar 30, 1988
ATS CRYPTOSPORIDIUM STAIN CONTROL SLIDES
K880962 · LJG
Alpha-Tec Systems, Inc.
Microbiology · 22d
Cleared Mar 30, 1988
ATS TRICHROME STAIN (WHEATLEY'S MODIFICATION)
K881042 · JTS
Alpha-Tec Systems, Inc.
Pathology · 19d
Cleared Mar 30, 1988
INTRACELLULAR AMYLOID HISTOLOGY CONTROL SLIDES
K881107 · LJG
Sigma Diagnostics, Inc.
Microbiology · 15d
Cleared Mar 30, 1988
INTRACELLULAR/EXTRACELLULAR IRON HISTOLOGY CONTROL
K881111 · LJG
Sigma Diagnostics, Inc.
Microbiology · 15d
Cleared Mar 29, 1988
SARA AGIE MONITOR
K874724 · CCK
Ppg/Applied Resources, Inc.
Anesthesiology · 132d
Cleared Mar 29, 1988
RATEMINDER V INFUSION PUMP
K875174 · FRN
Critikon Company, LLC
General Hospital · 103d
Cleared Mar 29, 1988
LC OXYGEN ANALYZER
K875183 · CCL
Ametek/Thermox Instruments Division
Anesthesiology · 98d
Cleared Mar 29, 1988
WASHING CATHETER
K875264 · OCX
Endovations
Gastroenterology & Urology · 98d
Cleared Mar 29, 1988
PORT-A-CATH IMPLANTABLE DRUG DELIVERY SYSTEM
K880072 · LLD
Pharmacia Deltec, Inc.
General Hospital · 78d
Cleared Mar 29, 1988
THUMPER MODEL P-1000
K880597 · BYI
Micro Tek Engineering
Anesthesiology · 47d
Cleared Mar 29, 1988
CERULLO SUCTION REGULATOR
K880704 · GCX
Aesculap Instruments Corp.
General Hospital · 36d
Cleared Mar 29, 1988
WAKO(TM) IGA-HA DIRECT
K880803 · CZP
Wako Chemicals USA, Inc.
Immunology · 29d
Cleared Mar 28, 1988
TECNOL LASER SURGICAL MASK
K874894 · FXX
Tecnol New Jersey Wound Care, Inc.
General Hospital · 118d
Cleared Mar 28, 1988
MODIFIED SCHNEIDER-SHILEY PRESSURE MANOMETER
K875322 · KRK
Schneider-Shilley (Usa)
Cardiovascular · 90d
Cleared Mar 28, 1988
MODIFIED SCHNEIDER-SHILEY WIRE TORQUER
K875323 · DQX
Schneider-Shilley (Usa)
Cardiovascular · 90d
Cleared Mar 28, 1988
COLORGENE FLUORESCENT DNA HYBRIDIZATION TEST / CMV
K875367 · GQM
Enzo Biochem, Inc.
Microbiology · 88d
Cleared Mar 28, 1988
OECO MEMBRANE OXYGNE & VAPOR ENRICHER MODEL OE-8
K880044 · CAW
Oxygen Enrichment Company, Ltd.
Anesthesiology · 82d
Cleared Mar 28, 1988
METATECH INTRACRANIAL PRESSURE MONITORING SYSTEM
K880154 · GWM
Metatech Corp.
Neurology · 75d
Cleared Mar 28, 1988
SINGLE PHASE DIAGNOSTIC X-RAY GENERATOR FX 350
K880532 · IZO
Fischer Imaging Corp.
Radiology · 48d