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
84097–84120 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 20, 1999
OPUS SPINAL SYSTEM
K993402 · MNI
Howmedica Osteonics Corp.
Orthopedic · 73d
Cleared Dec 20, 1999
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z46
K993432 · DXN
Rossmax International , Ltd.
Cardiovascular · 69d
Cleared Dec 20, 1999
BIRD V.I.P. GOLD/STERLING
K993449 · CBK
Bird Products Corp.
Anesthesiology · 69d
Cleared Dec 20, 1999
GREEN POWDERED LATEX EXAMINATION GLOVES
K993452 · LYY
Top Glove Sdn. Bhd.
General Hospital · 68d
Cleared Dec 20, 1999
PEPPER GREEN MINT POWDERED LATEX EXAMINATION GLOVES
K993605 · LYY
Top Glove Sdn. Bhd.
General Hospital · 56d
Cleared Dec 20, 1999
LAERDAL SUCTION UNIT,(4000) MODEL 78 00 20
K993668 · BTA
Laerdal Medical A/S
General & Plastic Surgery · 49d
Cleared Dec 20, 1999
ALATECH LATEX CONDOM
K993887 · HIS
Alatech Healthcare, LLC
Obstetrics & Gynecology · 34d
Cleared Dec 20, 1999
A & D MEDICALLIFESOURCE US-779PC & UA-779T DIGITAL BLOOD PRESSURE MONITORS
K993888 · DXN
A&D Engineering, Inc.
Cardiovascular · 34d
Cleared Dec 20, 1999
TITANIUM PEDIATRIC FEMORAL NAIL
K993956 · HSB
Biomet, Inc.
Orthopedic · 28d
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