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
129529–129552 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 28, 1989
TDXR ANALYZER WITH LITES TM LITHIUM CAROUSEL
K894222 · JJE
Abbott Laboratories
Toxicology · 101d
Cleared Sep 28, 1989
AMRESCO TRIGLYCERIDES REAGENTS (PRODUCTS 7730)
K894310 · CDT
American Research Products Co.
Chemistry · 76d
Cleared Sep 28, 1989
NIPRO NEEDLE HOLDER
K894372 · FMI
Pharma-Plast USA, Inc.
Chemistry · 73d
Cleared Sep 28, 1989
BLOOD DRAWING NEEDLE
K894374 · FMI
Pharma-Plast USA, Inc.
Chemistry · 73d
Cleared Sep 28, 1989
FPR AMIKACIN KIT
K894517 · KLQ
Colony Laboratories, Inc.
Toxicology · 70d
Cleared Sep 28, 1989
FPR AMIKACIN CALIBRATOR KIT
K894518 · DLG
Colony Laboratories, Inc.
Toxicology · 70d
Cleared Sep 28, 1989
FPR GENTAMICIN KIT
K894523 · LCQ
Colony Laboratories, Inc.
Toxicology · 70d
Cleared Sep 28, 1989
FPR GENTAMICIN CALIBRATOR KIT
K894524 · DLG
Colony Laboratories, Inc.
Toxicology · 70d
Cleared Sep 28, 1989
SHARPLAN SMOKE EVACUATION UNIT, MODEL 100
K894765 · FYD
Laser Industries , Ltd.
General Hospital · 64d
Cleared Sep 28, 1989
SINGLE (SPECIFIED) ANALYTE CONTROL (ASSAYED)
K894804 · JJX
Lifescan, Inc.
Chemistry · 62d
Cleared Sep 28, 1989
SERACHEM PLUS CLINICAL CHEMISTRY CONTROLS
K894852 · JJY
Instrumentation Laboratory CO
Chemistry · 59d
Cleared Sep 28, 1989
CO2 LASER BRONCHOSCOPE COUPLER
K894962 · GEX
Cuda Products Co.
General & Plastic Surgery · 52d
Cleared Sep 28, 1989
EXUSORB(TM) GRANULES
K894996 · FRO
Controlled Therapeutics Corp.
General & Plastic Surgery · 51d
Cleared Sep 28, 1989
MILENIA(TM) TOTAL IGE (MKIE1,5)
K895004 · DGC
Diagnostic Products Corp.
Immunology · 51d
Cleared Sep 28, 1989
BIOCLUSIVE* TRANSPARENT FILM DRESSING - NEW CLAIM
K895207 · FRO
Johnson & Johnson International
General & Plastic Surgery · 42d
Cleared Sep 28, 1989
OPSITE I.V. 3000
K895353 · KGX
Smith & Nephew United, Inc.
General & Plastic Surgery · 27d
Cleared Sep 28, 1989
BIO-COORDINATOR SYSTEM
K895398 · IKK
Bio-Harmonizer, Inc.
Physical Medicine · 21d
Cleared Sep 28, 1989
PRIMIDONE (FPIA) CALIBRATOR KIT
K895568 · DLJ
Tudor Laboratories, Inc.
Toxicology · 22d
Cleared Sep 28, 1989
VALPROIC ACID (FPIA) CALIBRATOR KIT
K895570 · DLJ
Tudor Laboratories, Inc.
Toxicology · 22d
Cleared Sep 27, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892635 · LYY
P.T. Multi Latexindo
General Hospital · 170d
Cleared Sep 27, 1989
PREEMICARE MODEL 2500 TRANSPORT WARMER
K893624 · FPL
Preemicare Corp.
General Hospital · 139d
Cleared Sep 27, 1989
COUNTERBORE FOR SS SUBMERGED SCREW PLANT
K894150 · DZJ
Artech Corp.
Dental · 105d
Cleared Sep 27, 1989
IRRIGATED DRILL FOR SS SUBMERGED SCREW PLANT
K894151 · DZJ
Artech Corp.
Dental · 105d
Cleared Sep 27, 1989
MODIFIED GEMINI ACETABULAR CUP
K894298 · JDI
Depuy, Inc.
Orthopedic · 97d