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
101473–101496 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 14, 1995
SERODIA ATG
K953066 · DDC
Fujirebio America, Inc.
Immunology · 45d
Cleared Aug 11, 1995
EPIDURAL NEEDLE
K942863 · BSP
Spinal Specialties, Inc.
Anesthesiology · 420d
Cleared Aug 11, 1995
9000 INFUSION PUMP
K944721 · FRN
Graseby Medical , Ltd.
General Hospital · 322d
Cleared Aug 11, 1995
BCW 600 POWER WHEELCHAIR
K945047 · ITI
Wheelchairs of Kansas
Physical Medicine · 301d
Cleared Aug 11, 1995
AUTOJECT 2
K945660 · KZH
Owen Mumford USA, Inc.
General Hospital · 267d
Cleared Aug 11, 1995
WRIGHT-LOC(TM) SPINAL FIXATION SYSTEM
K950074 · MNH
Wrightmedicaltechnologyinc
Orthopedic · 214d
Cleared Aug 11, 1995
NEEDLE SAFETY COVER
K950098 · CBT
Hammer-Plane, Inc.
Anesthesiology · 213d
Cleared Aug 11, 1995
SMART PLUG
K950120 · GEX
Hgm, Inc.
General & Plastic Surgery · 211d
Cleared Aug 11, 1995
DUPONT DIMENSION TOTAL PROTEIN METHOD
K950920 · CEK
Dupont Medical Products
Chemistry · 163d
Cleared Aug 11, 1995
JEDMED LARYNGEAL SCOPE
K950925 · EOQ
Jedmed Instrument Co.
Ear, Nose, Throat · 163d
Cleared Aug 11, 1995
ACROMED PEDICLE SCREW
K951116 · MNH
Acromed Corp.
Orthopedic · 154d
Cleared Aug 11, 1995
DX1-PORTABLE
K951157 · BZC
Creative Biomedics, Inc.
Anesthesiology · 150d
Cleared Aug 11, 1995
DX1
K951227 · BZG
Creative Biomedics, Inc.
Anesthesiology · 144d
Cleared Aug 11, 1995
ACCUSPORT LACTATE MONITORING SYSTEM LACTATE TEST STRIPS ACCUSPORT MONITOR
K951331 · KHP
Boehringer Mannheim Corp.
Chemistry · 140d
Cleared Aug 11, 1995
CHAMPION PHYSIOACOUSTICC RECLINER-TRANSPORTER CHAIR
K951414 · IRO
Champion Mfg. Corp.
Physical Medicine · 137d
Cleared Aug 11, 1995
ALKALINE PHOSPHATASE (ALP/AMP) PROCEDURE NO. 247
K951584 · CJE
Sigma Diagnostics, Inc.
Chemistry · 127d
Cleared Aug 11, 1995
INTRAMEDULARY FIXATION ROD
K951740 · HSB
Acu Med, Inc.
Orthopedic · 140d
Cleared Aug 11, 1995
COMMUNITY BALANCE PERFORMANCE MONITOR OR COMMUNITY BPM
K951771 · KHX
Sms Technologies, Ltd.
Physical Medicine · 116d
Cleared Aug 11, 1995
MODIFIED HUMAN TUBAL FLUID (MHTF) WITH/WITHOUT PENICILLIN G DOLIUM,...
K951835 · MFD
Life Technologies, Inc.
Obstetrics & Gynecology · 113d
Cleared Aug 11, 1995
CLEAR HUB SPINAL NEEDLE, 18, 20, 22, 25 GA.
K951949 · BSP
Baxter Healthcare Corp
Anesthesiology · 107d
Cleared Aug 11, 1995
OSTEONICS SERIES 7000 TOTAL KNEE FULL TIBIAL BONE AUGEMENTATION BLOCKS & WEDGES
K951956 · JWH
Osteonics Corp.
Orthopedic · 107d
Cleared Aug 11, 1995
RICH-MAR CM-II COMBINED MUSCLE STIMULATOR, INTERFERENTIAL, TENS & THERAPEUTIC...
K952089 · LIH
Rich-Mar Corp.
Neurology · 100d
Cleared Aug 11, 1995
AMIGO GRAND TOUR
K952112 · INI
Amigo Mobility Intl., Inc.
Physical Medicine · 98d
Cleared Aug 11, 1995
HEWLETT-PACKARD MODEL M1264B CATHSTATION
K952173 · DPS
Hewlett-Packard Co.
Cardiovascular · 95d