FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
78577–78600 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 27, 2001
DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
K010159 · LTT
Dade Microscan, Inc.
Microbiology · 191d
Cleared Jul 27, 2001
QUANTA PLEX ENA PROFILE 4
K011140 · LLL
Inova Diagnostics, Inc.
Immunology · 105d
Cleared Jul 27, 2001
SYNTHES CURVED RECONSTRUCTION PLATE
K011334 · HRS
Synthes (Usa)
Orthopedic · 86d
Cleared Jul 27, 2001
SYNTHS ONE-THIRD TUBULAR DCL PLATE
K011335 · HRS
Synthes (Usa)
Orthopedic · 86d
Cleared Jul 27, 2001
HYDRO2, HS-75
K011914 · HQD
Innovision, Inc.
Ophthalmic · 38d
Cleared Jul 27, 2001
ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-5
K012028 · LFL
Misonix, Inc.
General & Plastic Surgery · 29d
Cleared Jul 27, 2001
BRAUN PRECISION SENSOR PRO, MODEL BP 2590
K012035 · DXN
Braun GmbH
Cardiovascular · 28d
Cleared Jul 27, 2001
MODIFICATION TO:HU-FRIEDY BRAND SATIN SWIVEL ULTRASONIC INSERT
K012060 · ELC
Hu-Friedy Mfg. Co., Inc.
Dental · 25d
Cleared Jul 27, 2001
KLS-MARTIN TEMPORARY CONDYLAR IMPLANT
K990667 · NEI
KLS-Martin L.P.
Dental · 878d
Cleared Jul 26, 2001
GSI AUDERA
K011135 · EWO
Nicolet Biomedical
Ear, Nose, Throat · 104d
Cleared Jul 26, 2001
RF-IVD WIRELESS DOSIMETER-MODEL 1133
K011332 · IYE
Sun Nuclear Corp.
Radiology · 85d
Cleared Jul 26, 2001
METRONIC SOFAMOR DANEK CEMENT RESTRICTOR
K011998 · JDK
Medtronic Sofamor Danek, Inc.
Orthopedic · 29d
Cleared Jul 26, 2001
VIKING OPTIMA GUIDING CATHETER
K012002 · DQY
Guidant Corp.
Cardiovascular · 29d
Cleared Jul 26, 2001
MODIFICATION TO THERMAL ANGEL
K012031 · BSB
Estill Medical Technologies, Inc.
Hematology · 28d
Cleared Jul 26, 2001
THE LPS - CONTINUUM TM HYBRID TIBIA, MODELS 32-5886-2Y-XX (ZIMMER) AND...
K012095 · JWH
Implex Corp.
Orthopedic · 21d
Cleared Jul 26, 2001
TERATECH MODEL 2000 HANDHELD ULTRASOUND SYSTEM WITH DOPPLER AND HARMONIC...
K012191 · IYN
Teratech Corp.
Radiology · 13d
Cleared Jul 25, 2001
LASERSKIN DRESSING
K001508 · MGP
Fidia Advanced Biopolymers Srl
General & Plastic Surgery · 436d
Cleared Jul 25, 2001
TACKER, MODEL R65-933
K003949 · OCW
A & A Medical, Inc.
Gastroenterology & Urology · 216d
Cleared Jul 25, 2001
DRAINAGE CATHETER OR FOLEY CATHETER
K010006 · EZL
Applied Medical Resources Corp.
Gastroenterology & Urology · 204d
Cleared Jul 25, 2001
TREMOROMETER
K010270 · GYD
Flexable Systems, Inc.
Neurology · 177d
Cleared Jul 25, 2001
LIPOPRINT SYSTEM, LDL SUBFRACTIONS
K010337 · JHO
Quantimetrix Corp.
Chemistry · 170d
Cleared Jul 25, 2001
MEDIFIX URETEROSCOPE
K011325 · FGB
Medifix, Inc.
Gastroenterology & Urology · 85d
Cleared Jul 25, 2001
HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT
K011689 · LPS
Catch, Inc.
Chemistry · 55d
Cleared Jul 25, 2001
HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT
K011692 · LPS
Intersect Systems, Inc.
Chemistry · 55d