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
126265–126288 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 12, 1990
ATRAUMAX SURGICAL CLAMP MODEL FOG-5048, 75MM SIDE
K901565 · DXC
Applied Vascular Devices, Inc.
Cardiovascular · 70d
Cleared Jun 12, 1990
PROLACTIN (LACTOGEN) TEST SYSTEM
K901673 · CFT
Baxter Healthcare Corp
Chemistry · 63d
Cleared Jun 12, 1990
MODIFIED LABELING FOR ACA LIPASE ANALYTICAL TEST
K901858 · CET
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 49d
Cleared Jun 12, 1990
7620 REMOTE CENTRAL STATION REPEATER
K901884 · DXJ
Marquette Electronics, Inc.
Cardiovascular · 47d
Cleared Jun 12, 1990
SORBA MODEL CIC-1000 W/NEW ELECTRODES
K901926 · DXG
Sorba Medical Systems, Inc.
Cardiovascular · 43d
Cleared Jun 12, 1990
BLOOD GAS/ELECTROLYTE/CO-OXIMETER CONTROLS
K902095 · JJY
Phoenix Diagnostics, Inc.
Chemistry · 35d
Cleared Jun 12, 1990
HI CHEM ISE REAGENTS (PRODUCTS #88960 AND #88964)
K902155 · JIM
Hichem Diagnostics
Chemistry · 28d
Cleared Jun 12, 1990
COULTER SERUM IRON/UIBC REAGENT
K902173 · JIY
Coulter Corp.
Chemistry · 29d
Cleared Jun 12, 1990
COULTER UREA NITROGEN REAGENT
K902175 · CDQ
Coulter Corp.
Chemistry · 29d
Cleared Jun 12, 1990
COULTER DIRECT BILIRUBIN
K902199 · CIG
Coulter Corp.
Chemistry · 27d
Cleared Jun 12, 1990
COULTER CARBON DIOXIDE REAGENT
K902229 · KHS
Coulter Corp.
Chemistry · 26d
Cleared Jun 12, 1990
BLOOD GASES/PC02, PO2 ANALYSIS PRODUCTS
K902267 · CHL
Phoenix Diagnostics, Inc.
Chemistry · 22d
Cleared Jun 11, 1990
MEDITHERM
K894152 · IMI
Medical Equipment Designs, Inc.
Physical Medicine · 362d
Cleared Jun 11, 1990
AUSONICS 5000
K896714 · IYO
Ausonics Pty , Ltd.
Radiology · 194d
Cleared Jun 11, 1990
TRANS/R - FP(3)
K900016 · FCY
CIVCO Medical Instruments Co., Inc.
Gastroenterology & Urology · 160d
Cleared Jun 11, 1990
DYNATRON 330 BODY COMPOSITION ANALYZER
K900321 · DSB
Dynatronics Laser Corp.
Cardiovascular · 139d
Cleared Jun 11, 1990
SYNECTICS LIBERTY SYSTEM, PC POLYGRAF & POLYGRAM
K900494 · FAP
Synectics-Dantec
Gastroenterology & Urology · 129d
Cleared Jun 11, 1990
CAAS UNICOMPARMENTAL KNEE SYSTEM
K900619 · HSX
Techmedica, Inc.
Orthopedic · 123d
Cleared Jun 11, 1990
INSITE STEERABLE GUIDEWIRE
K901224 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 89d
Cleared Jun 11, 1990
PLEXUS 3.5(TM) PEDIATRIC HOLLOW FIBER OXYGENATOR
K901249 · DTZ
Shiley, Inc.
Cardiovascular · 87d
Cleared Jun 11, 1990
PLEXUS 2(TM) INFANT HOLLOW FIBER OXYGENATOR
K901250 · DTZ
Shiley, Inc.
Cardiovascular · 87d
Cleared Jun 11, 1990
BIOPSY FORCEPS (NON-RIGID)
K901339 · KNW
Applied Medical Technologies
Gastroenterology & Urology · 81d
Cleared Jun 11, 1990
DISP. ENDOSCOPE CLEANING BRUSH - SQUEEKY CLEAN
K901439 · FEB
Telemed Systems, Inc.
General Hospital · 77d
Cleared Jun 11, 1990
CORPAK GASTROSTOMY TUBE
K901501 · KGC
Corpak Co.
Gastroenterology & Urology · 73d