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
83593–83616 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 20, 1999
ABSOLUTE ABSORBABLE INTERFERENCE SCREW
K993975 · HWC
Innovasive Devices, Inc.
Orthopedic · 26d
Cleared Dec 20, 1999
PRE-POWDERED VINYL EXAM GLOVE, NON STERILE
K994036 · LYZ
Shanghai Champion Plastic Products...
General Hospital · 21d
Cleared Dec 20, 1999
STRYKER T4 POWER PACK, STRYKER T4 EIGHT STATION BATTERY CHARGER, STRYKER T4...
K994053 · FYA
Stryker Instruments
General Hospital · 20d
Cleared Dec 20, 1999
SONOHEART HAND-CARRIED ECHOCARDIOGRAPHY SYSTEM
K994096 · IYN
Sonosite,Inc.
Radiology · 17d
Cleared Dec 17, 1999
MULTITAK SS
K993115 · MAI
Bonutti Research, Inc.
Orthopedic · 88d
Cleared Dec 17, 1999
BIOTEQUE A.V. FISTULA NEEDLE SET
K993118 · FIE
Bioteque Corp.
Gastroenterology & Urology · 88d
Cleared Dec 17, 1999
QK-WIDE BAND SPECTRUM THERAPEUTIC APPARATUS, MODELS CO1A, CO1B, CO1C, CO1D,...
K993123 · ILY
United Pacific Co., Ltd.
Physical Medicine · 88d
Cleared Dec 17, 1999
ULTRA-GARMENT ELECTRODE
K993130 · GXY
Newwave Medical, LLC
Neurology · 88d
Cleared Dec 17, 1999
YP 45/15-BP
K993139 · DTB
Biotronik, Inc.
Cardiovascular · 88d
Cleared Dec 17, 1999
INTRALASE 600C LASER KERATOME
K993153 · GEX
Intra Lase Corp.
General & Plastic Surgery · 87d
Cleared Dec 17, 1999
HEM-O-LOK SMX POLYMER CLIPS, MODEL 544220, HEM-0-LOK MLX POLYMER CLIPS, MODEL...
K993157 · FZP
Weck Closure Systems
General & Plastic Surgery · 87d
Cleared Dec 17, 1999
EIM-107 PREP-CHECK
K993202 · GZO
General Devices
Neurology · 84d
Cleared Dec 17, 1999
RTD ARM ASSISTIVE ROBOTIC DEVICE
K993443 · ITI
Rehabilitation Technologies Division
Physical Medicine · 66d
Cleared Dec 17, 1999
OMNIAXIAL CONNECTOR
K993926 · MNH
Ortho Tec, LLC
Orthopedic · 29d
Cleared Dec 17, 1999
ORATEC SPINECATH INTRADISCAL CATHETER, MODEL 920002
K993967 · GEI
Oratec Interventions, Inc.
General & Plastic Surgery · 24d
Cleared Dec 17, 1999
INNOVAQUARTZ GENERAL SHAPE LASER FIBER
K994010 · GEX
Innovaquartz
General & Plastic Surgery · 21d
Cleared Dec 16, 1999
FRUCTOSAMINE, MODEL FR 106-01
K991246 · LCP
A.P. Total Care, Inc.
Chemistry · 248d
Cleared Dec 16, 1999
VERDICT -II OPIATES 2000
K992111 · DJG
Medtox Diagnostics, Inc.
Toxicology · 177d
Cleared Dec 16, 1999
COPALIS TREPONEMAL ANTIGEN TOTAL ANTIBODY ASSAY
K992552 · LIP
DiaSorin, Inc.
Microbiology · 139d
Cleared Dec 16, 1999
SURE-WAY REUSABLE SHARPS CONTAINER
K992626 · FMI
Sure-Way Systems, Inc.
General Hospital · 133d
Cleared Dec 16, 1999
PATIENT LATEX EXAMINATION POWDER-FREE POLYMER COATED GLOVES
K992676 · LYY
Wear Safe Malaysia Sdn. Bhd.
General Hospital · 128d
Cleared Dec 16, 1999
PATIENT LATEX EXAMINATION GLOVE POWDERED & POWDER FREE, STERILE
K992681 · LYY
Wear Safe Malaysia Sdn. Bhd.
General Hospital · 128d
Cleared Dec 16, 1999
INTRAY GC
K993033 · JTY
Biomed Diagnostics, Inc.
Microbiology · 98d
Cleared Dec 16, 1999
TALON ANCHOR SNAP-PAK
K993327 · DZL
Mitek Products
Dental · 73d