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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
128929–128952 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 28, 1989
DELTATEST (R) LIPASE II
K893718 · CET
Electro-Nucleonics, Inc.
Chemistry · 134d
Cleared Sep 28, 1989
EZ-BEAD DIGOXIN EIA KIT
K893843 · KXT
Immunotech Corp.
Toxicology · 126d
Cleared Sep 28, 1989
PLUME-AWAY SMOKE EVACUATION SYSTEM
K894038 · FYD
Laser Technologies Group, Inc.
General Hospital · 114d
Cleared Sep 28, 1989
TARGET THERAPEUTICS TRACKER LF CATHETER
K894105 · DQY
Target Therapeutics
Cardiovascular · 111d
Cleared Sep 28, 1989
VARI-SET
K894111 · LDR
Sonex Medical
General Hospital · 108d
Cleared Sep 28, 1989
BILIBLANKET PHOTOTHERAPY DEVICE
K894129 · LBI
Ohmeda Medical
General Hospital · 108d
Cleared Sep 28, 1989
OBTURATOR
K894157 · DYB
Argon Medical Corp.
Cardiovascular · 106d
Cleared Sep 28, 1989
HAND TOOLS FOR ARTECH TYPE SS SUBMERGED SCREW IMPL
K894160 · DZE
Artech Corp.
Dental · 106d
Cleared Sep 28, 1989
LATEX EXAMINATION GLOVES
K894193 · LYY
Hasil Getah Gulungan Pertama
General Hospital · 108d
Cleared Sep 28, 1989
ROSCO PYRR
K894221 · JTO
Pro-Lab, Inc.
Microbiology · 101d
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