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
113545–113568 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 22, 1993
VOLUME VENTILATORS
K932560 · BZO
Life Shield Healthcare Products, Inc.
Anesthesiology · 56d
Cleared Jul 22, 1993
GUEDEL AIRWAYS
K932561 · BTR
Life Shield Healthcare Products, Inc.
Anesthesiology · 56d
Cleared Jul 22, 1993
ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS
K932575 · CAI
Med-Plastics Intl., Inc.
Anesthesiology · 56d
Cleared Jul 22, 1993
PEDIATRIC TEMPERATURE MONITORING CIRCUITS
K932576 · CAI
Med-Plastics Intl., Inc.
Anesthesiology · 56d
Cleared Jul 22, 1993
PEDIATRIC GAS SAMPLING
K932577 · CAI
Med-Plastics Intl., Inc.
Anesthesiology · 56d
Cleared Jul 22, 1993
ADULT GAS SAMPLING CIRCUITS
K932578 · CAI
Med-Plastics Intl., Inc.
Anesthesiology · 56d
Cleared Jul 22, 1993
PEDIATRIC GAS SAMPLING CIRCUITS
K932589 · CAI
Merit Medical Systems, Inc.
Anesthesiology · 56d
Cleared Jul 22, 1993
ADULT GAS SAMPLING CIRCUITS
K932590 · CAI
Merit Medical Systems, Inc.
Anesthesiology · 56d
Cleared Jul 22, 1993
MANUAL TILT RECLINE CHAIR (MTC)
K932639 · IOR
Labac Systems, Inc.
Physical Medicine · 50d
Cleared Jul 22, 1993
PRECISION MED PRODUCTS LTD VOLUME VENTILATORS
K932712 · BZO
Precision Med Products, Ltd.
Anesthesiology · 48d
Cleared Jul 22, 1993
MODEL M4501,M4502,M4503,M4504,M4505 TILT TABLE
K932749 · INQ
Med Mart, Inc.
Physical Medicine · 44d
Cleared Jul 22, 1993
ROCHE ABUSCREEN TRI-LEVEL REFERENCE CONTROLS
K932753 · DKB
Roche Diagnostic Systems, Inc.
Toxicology · 55d
Cleared Jul 22, 1993
ABUSCREEN CALIBRATION STANDARD
K932754 · DKB
Roche Diagnostic Systems, Inc.
Toxicology · 55d
Cleared Jul 22, 1993
HAVERICH ORTHOPAEDIC CYCLES
K932795 · IOR
Haverich Ortho-Sport (Usa), Inc.
Physical Medicine · 43d
Cleared Jul 22, 1993
SRX COMP ULTRALIGHT WHEELCHAIR
K932927 · IOR
Medical Composite Technology, Inc.
Physical Medicine · 37d
Cleared Jul 21, 1993
ACUFEX(R) TAG(TM)
K911293 · JDR
Acufex Microsurgical, Inc.
Orthopedic · 849d
Cleared Jul 21, 1993
MONOTRODE CUTANEOUS ELECTRODE
K915864 · GXY
Henley Intl.
Neurology · 568d
Cleared Jul 21, 1993
EMITENS ELECTRODES
K922393 · GXY
Electronic Monitors, Inc.
Neurology · 427d
Cleared Jul 21, 1993
CONSENSUS(TM) TOTAL HIP SYSTEM
K922561 · JDL
U.S. Medical Products, Inc.
Orthopedic · 413d
Cleared Jul 21, 1993
AS/3 COP MODULE
K922876 · CBQ
Datex Division Instrumentarium Corp.
Anesthesiology · 401d
Cleared Jul 21, 1993
CAPNOMAC ULTIMA ANESTHESIA MONITOR
K923276 · CBQ
Datex Division Instrumentarium Corp.
Anesthesiology · 380d
Cleared Jul 21, 1993
HAYEK OSCILLATOR(TM)
K924341 · BYT
Respironics, Inc.
Anesthesiology · 328d
Cleared Jul 21, 1993
REFLEX(R) ECA
K924929 · HBT
Richard-Allan Medical
General & Plastic Surgery · 294d
Cleared Jul 21, 1993
NORTEC STERILE WATER FOR CATHETER BALLOON INFLATIO
K925161 · KNY
North American Sterilization &...
Gastroenterology & Urology · 281d