FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
100033–100056 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 31, 1996
TRILASE 2940 ERBIUM LASER
K954013 · GEX
Schwartz Electro-Optics, Inc.
General & Plastic Surgery · 159d
Cleared Jan 31, 1996
GEL MASK
K954207 · BZD
Respironics, Inc.
Anesthesiology · 146d
Cleared Jan 31, 1996
LACTOSORB SUTURE ANCHOR
K954443 · JDR
Poly-Medics,Inc.
Orthopedic · 128d
Cleared Jan 31, 1996
ILLUMINATOR
K954787 · CCW
Hospitak, Inc.
Anesthesiology · 105d
Cleared Jan 31, 1996
HOLGRATH COMBINED SPINAL EPIDURAL NEEDLE SET
K954835 · CAZ
Holgrath Medical Technologies, Inc.
Anesthesiology · 103d
Cleared Jan 31, 1996
PROFIX POSTERIOR-STABILIZED KNEE SYSTEM
K954909 · JWH
Smith & Nephew Richards, Inc.
Orthopedic · 98d
Cleared Jan 31, 1996
BIOFIX BIODEGRADABLE SELF-REINFORCED POLY-L-LACTIDE (SR-PLLA) MINI-TACK
K955003 · MAI
Bioscience, Inc.
Orthopedic · 91d
Cleared Jan 31, 1996
RIM FLARE ACETABULAR COMPONENT
K955033 · LPH
Intermedics Orthopedics
Orthopedic · 90d
Cleared Jan 31, 1996
AT-III CONTROL PLASMA KIT
K955040 · GGC
American Bioproducts Co.
Hematology · 89d
Cleared Jan 31, 1996
MAXI-TORQUE PLUS ANGIOGRAPHIC CATHETER
K955111 · DQO
Adam Spence Corp.
Cardiovascular · 84d
Cleared Jan 31, 1996
ACE-DUPONT COMPOSITE RINGS
K955388 · LXT
Ace Medical Co.
Orthopedic · 68d
Cleared Jan 31, 1996
MICROSURGE THORACOSCOPIC INSTRUMENTS
K955408 · GCJ
Microsurge, Inc.
General & Plastic Surgery · 65d
Cleared Jan 31, 1996
X6000D SILENT SUN LIGHT SOURCE
K955510 · FST
Products For Medicine
General & Plastic Surgery · 58d
Cleared Jan 31, 1996
OLYMPUS URIC ACID REAGENT
K955752 · CDO
Olympus America, Inc.
Chemistry · 43d
Cleared Jan 30, 1996
SOFAMOR, LAURAIN DEWALD ANTERIOR FIXATION
K940744 · KWQ
Sofamor Co.
Orthopedic · 712d
Cleared Jan 30, 1996
PHARMACIA CAP SYSTEM PHADIATOP FEIA
K941993 · DHB
Pharmacia, Inc.
Immunology · 645d
Cleared Jan 30, 1996
JOSTRA HL-20 INTEGRATED PERFUSION SYSTEM
K943803 · DTQ
Janus Biomedical, Inc.
Cardiovascular · 544d
Cleared Jan 30, 1996
HUMAN BETA-2 MICROGLOBULIN ENHANCED RADIAL IMMUNODIFFUSION KIT
K946068 · JZG
The Binding Site, Ltd.
Immunology · 433d
Cleared Jan 30, 1996
HUMAN BETA-2 MICROGLOBULIN ENHANCED NEPHELOMETRIC KIT
K946069 · JZG
The Binding Site, Ltd.
Immunology · 433d
Cleared Jan 30, 1996
HUMAN BETA-2 MICROGLOBULIN TURBINDIMETRIC KIT
K946070 · JZG
The Binding Site, Ltd.
Immunology · 433d
Cleared Jan 30, 1996
CMV BRITE ANTIGENEMIA TEST KIT
K951550 · LIN
Biotest Diagnostics Corp.
Microbiology · 301d
Cleared Jan 30, 1996
JET NEBULIZER
K952249 · CAF
Devilbiss Health Care, Inc.
Anesthesiology · 260d
Cleared Jan 30, 1996
CHROM Z-PROTEIN C, CAT. NO. 5243
K952666 · GGP
Helena Laboratories
Hematology · 232d
Cleared Jan 30, 1996
DARWIN HYPODERMIC SAFETY SYSTEM (DHSS)
K952837 · FMI
Emk Enterprises, LLC
General Hospital · 225d