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
81409–81432 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 21, 2000
DINAMAP PRO 1000 MONITOR, MODEL 1000
K002248 · DXN
Critikon Company, LLC
Cardiovascular · 58d
Cleared Sep 21, 2000
MODIFICATION TO ACRYDERM SILVER ANTIMICROBIAL WOUND DRESSING, MODELS 1041,...
K002599 · FRO
Acrymed, Inc.
General & Plastic Surgery · 31d
Cleared Sep 21, 2000
DATEX-OHMEDA D-TEC PLUS ANESTHESIA VAPORIZER
K002878 · CAD
Datex-Ohmeda, Inc.
Anesthesiology · 6d
Cleared Sep 21, 2000
SOPHY SU8 PRESSURE ADJUSTABLE VALVE
K992465 · JXG
Sophysa SA
Neurology · 426d
Cleared Sep 20, 2000
VIGILANCE CCO/CEDV & VIGILANCE CCO/SVO2/CEDV MONITORS
K000664 · DXG
Baxter Healthcare Corp
Cardiovascular · 205d
Cleared Sep 20, 2000
MICOR CONDUCTION CATHETER
K001717 · BSO
Micor, Inc.
Anesthesiology · 107d
Cleared Sep 20, 2000
POLESTAR N-10
K002242 · LNH
Odin Technologies , Ltd.
Radiology · 58d
Cleared Sep 20, 2000
ALOKA UST-5280-5
K002784 · ITX
Aloka Co., Ltd.
Radiology · 14d
Cleared Sep 20, 2000
CLINICAL SPECULAR MICROSCOPE, MODEL HAI CL-1000XYZ
K994340 · HLI
Hai Laboratories, Inc.
Ophthalmic · 272d
Cleared Sep 19, 2000
BUFFLIGHT CLT SURGICAL LASER SYSTEM
K000727 · GEX
Y-Beam Technologies, Inc.
General & Plastic Surgery · 197d
Cleared Sep 19, 2000
CANDELA SPTL-1B PULSED DYE LASER
K001093 · GEX
Candela Corp.
General & Plastic Surgery · 168d
Cleared Sep 19, 2000
PROSTEC 125I BRANCHYTHERAPY SNAPSEED
K001366 · KXK
Prostec, LLC
Radiology · 172d
Cleared Sep 19, 2000
OCCU-FLO PUNCTUM PLUGS
K001768 · LZU
U.S. Iol, Inc.
Ophthalmic · 99d
Cleared Sep 19, 2000
BABY DOPPLEX 4002-TWINS, MODEL BD4002
K001882 · HGM
Huntleigh Healthcare, Inc.
Obstetrics & Gynecology · 90d
Cleared Sep 19, 2000
POLY PER-Q-CATH PICC CATHETER,MODEL 3236100 AND POLY PER-Q-CATH MIDLINE...
K001901 · LJS
C.R. Bard, Inc.
General Hospital · 89d
Cleared Sep 19, 2000
KSEA PERCUTANEOUS FORAMINOSCOPY SET
K001918 · HRX
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 88d
Cleared Sep 19, 2000
PAIN CARE 3000
K002073 · MEB
Breg, Inc.
General Hospital · 71d
Cleared Sep 19, 2000
ULTRASORB SUTURE ANCHOR
K002413 · MAI
Li Medical Technologies, Inc.
Orthopedic · 43d
Cleared Sep 19, 2000
ASCENT KNEE SYSTEM
K002678 · JWH
Biomet, Inc.
Orthopedic · 22d
Cleared Sep 19, 2000
ASCENT XXL OPEN BOX FEMORAL COMPONENT
K002735 · JWH
Biomet, Inc.
Orthopedic · 18d
Cleared Sep 19, 2000
BIS ENGINE
K002837 · OLW
Aspect Medical Systems, Inc.
Neurology · 7d
Cleared Sep 18, 2000
RAEBBITT/EVOLUTION POWERED WHEELCHAIR
K000678 · ITI
Otto Bock Orthopedic Industry, Inc.
Physical Medicine · 202d
Cleared Sep 18, 2000
SERAGARD VASCULAR ACCESS PATCH
K001175 · FMI
Platinum Services, Inc.
General Hospital · 160d
Cleared Sep 18, 2000
ACTI-FLEX IV ADMINISTRATION SET
K001599 · FPA
R-Group Intl.
General Hospital · 117d