FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
115849–115872 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 30, 1992
KING DIAGNOSTICS MAGNESIUM REAGENT
K923927 · JGJ
King Diagnostics, Inc.
Chemistry · 56d
Cleared Sep 29, 1992
AUTO SUTURE SURGIPORT DISPOSABLE ANCHORING DEVICE
K915331 · HET
United States Surgical, A Division of...
Obstetrics & Gynecology · 308d
Cleared Sep 29, 1992
HYSORB WOUND DRESSING
K921502 · KMF
Kingston Technologies, Inc.
General & Plastic Surgery · 182d
Cleared Sep 29, 1992
IMX(R) GLYCATED HEMOGLOBIN
K921831 · LCP
Abbott Laboratories
Hematology · 166d
Cleared Sep 29, 1992
QUANTA LITE(TM) IGA ACA
K922351 · MID
Inova Diagnostics, Inc.
Immunology · 133d
Cleared Sep 29, 1992
SUMMIT NUCLEAR VISION 1024RZ GAMMA CAMERA SYSTEM
K922427 · KPS
Summit Nuclear
Radiology · 130d
Cleared Sep 29, 1992
THROMBIN CLOT TIME TEST PROCEDURE
K923220 · GJA
Medical Laboratory Automation...
Hematology · 90d
Cleared Sep 29, 1992
PE 400IR, PE 400T, PE 400E
K923234 · EPF
Phonic Ear, Inc.
Ear, Nose, Throat · 90d
Cleared Sep 29, 1992
ARGUS PET SYSTEM
K923309 · KPS
GE Medical Systems
Radiology · 84d
Cleared Sep 29, 1992
OPTIBOND
K923546 · KLE
Kerr Corporation (Danbury)
Dental · 75d
Cleared Sep 29, 1992
PALADISC LC
K923549 · EBH
Heraeus Kulzer, Inc.
Dental · 75d
Cleared Sep 29, 1992
BURNOUT MATERIAL
K923586 · EGD
Dentsply Intl.
Dental · 71d
Cleared Sep 29, 1992
ANALYZER: NOVA 10 CRT ANALYZER & QUALI CONT MATER
K923806 · JGS
Nova Biomedical Corp.
Chemistry · 62d
Cleared Sep 29, 1992
BISCO UNIVERSAL BOND-3
K923842 · KLE
Bisco, Inc.
Dental · 60d
Cleared Sep 29, 1992
ATAC 6000 CHEMISTRY ANALYZER
K924084 · JJE
Bio-Chem Laboratory Systems, Inc.
Chemistry · 47d
Cleared Sep 28, 1992
CONDUCTIVE SURGIGRIP SPIRAL SLEEVE
K915338 · HET
United States Surgical, A Division of...
Obstetrics & Gynecology · 307d
Cleared Sep 28, 1992
LACERATTION TRAY
K920763 · KDD
Sterile Concepts, Inc.
General & Plastic Surgery · 222d
Cleared Sep 28, 1992
DIASLIDE URINE CULTURING DEVICE
K921045 · JXA
Savyon Diagnostics , Ltd.
Microbiology · 208d
Cleared Sep 28, 1992
SAFE-DWELL PLUS CENTRAL VENOUS CATHETER
K921270 · FOZ
Bd Becton Dickinson Vacutainer...
General Hospital · 195d
Cleared Sep 28, 1992
SIL-MED FLAT SUCTION DRAIN
K921424 · GBX
Sil-Med Corp.
General & Plastic Surgery · 188d
Cleared Sep 28, 1992
ULTRADENT PRODUCT DENTIN CONDITION & SEAL PROD LIN
K921599 · EBC
Ultradent Products, Inc.
Dental · 178d
Cleared Sep 28, 1992
ULTRADENT PROD LI CURED PIT/FISSURE SEAL PROD LINE
K921600 · EBC
Ultradent Products, Inc.
Dental · 178d
Cleared Sep 28, 1992
SONOS 500, 1000, 1500/SONOS OR ULTRASOUND IMAG SYS
K921863 · GXW
Hewlett-Packard Co.
Radiology · 164d
Cleared Sep 28, 1992
SUMMIT NUCLEAR VISION T-22 GAMMA CAMERA SYSTEM
K922426 · KPS
Summit Nuclear
Radiology · 129d