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
80329–80352 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 24, 2000
SALUMEDICA NERVE CUFF
K002098 · JXI
Salumedica, LLC
Neurology · 136d
Cleared Nov 24, 2000
COD COMPRESSION OSTEOTOMY DEVICE
K002184 · HRS
Walter Abendschein, M.D.
Orthopedic · 128d
Cleared Nov 24, 2000
ONCOLOGY SALVAGE SYSTEM
K002757 · JDI
Biomet, Inc.
Orthopedic · 80d
Cleared Nov 24, 2000
HYDROCISION ARTHROJET SYSTEM WITH CAUTERY AND BURR
K002764 · HRX
Hydrocision, Inc.
Orthopedic · 80d
Cleared Nov 24, 2000
LICOX CMP MONITOR-AC3.1, LICOX IMC OXYGEN CATHETERS-CC1,CC1.SB LUICOX IMC...
K002765 · GWM
Integra Neurosciences
Neurology · 80d
Cleared Nov 24, 2000
IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL)
K002886 · LZK
Implantech Associates, Inc.
General & Plastic Surgery · 70d
Cleared Nov 24, 2000
METRX SYSTEM
K002931 · HRX
Medtronic Sofamor Danek, Inc.
Orthopedic · 65d
Cleared Nov 24, 2000
CYTOPLAST SUTURE
K003028 · NBY
Osteogenics Biomedical, Inc.
General & Plastic Surgery · 57d
Cleared Nov 24, 2000
IMAGE VASCULAR LASER
K003046 · GEX
Sciton, Inc
General & Plastic Surgery · 56d
Cleared Nov 24, 2000
VERSALINK TITANIUM ROD-TO-ROD COUPLERS
K003384 · MNH
Osteotech, Inc.
Orthopedic · 24d
Cleared Nov 24, 2000
ALUMINA V40 HEAD
K003413 · LZO
Howmedica Osteonics Corp.
Orthopedic · 22d
Cleared Nov 24, 2000
ISS OFFSET HEADS
K003428 · HSD
Biomet, Inc.
Orthopedic · 21d
Cleared Nov 22, 2000
PC ECG 1200
K000404 · MWI
Norav Medical , Ltd.
Cardiovascular · 289d
Cleared Nov 22, 2000
ALPHA OMEGA DUAL COOLER-HEATER
K001520 · DWC
Alpha Omega, Inc.
Cardiovascular · 190d
Cleared Nov 22, 2000
SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET
K001563 · FGO
Scion Cardiovascular, Inc.
Gastroenterology & Urology · 187d
Cleared Nov 22, 2000
CODA INCUBATOR CELLMATE
K001600 · MQG
Intl., Inc.
Obstetrics & Gynecology · 182d
Cleared Nov 22, 2000
COMFIT CHEMO PLUS PLUS POWDER FREE NITRILE EXAMINATION GLOVES (TESTED FOR USE...
K001613 · LZA
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 181d
Cleared Nov 22, 2000
BIO-RAD %CDT TIA
K001651 · JJX
Axis-Shield Biochemicals, Asa
Chemistry · 176d
Cleared Nov 22, 2000
T.I.M.S., VERSION 2.00
K001947 · LLZ
Total Medical Information Management...
Radiology · 149d
Cleared Nov 22, 2000
PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM...
K002024 · GRY
Panbio, Inc.
Microbiology · 142d
Cleared Nov 22, 2000
DRG PURETONE STETHOSCOPE WITH DRG ANTIMICROBIAL, STETHOSCOPE DIAPHRAGM, MODEL...
K002047 · DQD
Doctor'S Research Group, Inc.
Cardiovascular · 139d
Cleared Nov 22, 2000
BRANAN MEDICAL CORPORATION MONITECT AMPHETAMINE DRUG SCREEN TEST
K002266 · DKZ
Branan Medical Corporation
Toxicology · 120d
Cleared Nov 22, 2000
BRANAN MEDICAL CORPORATION MONITECT PCP DRUG SCREEN TEST, MODEL 160C AND 160D
K002272 · LCM
Branan Medical Corp.
Toxicology · 119d
Cleared Nov 22, 2000
BRANAN MEDICAL CORPORATION MONITECT BARBITURATES DRUG SCREEN TEST
K002337 · DIS
Branan Medical Corporation
Toxicology · 113d