Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

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

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175,820 results
142921–142944 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 24, 1986
MODEL 1000 OPHTHALMIC LASER SYSTEM
K862987 · HQF
CooperVision, Inc.
Ophthalmic · 48d
Cleared Sep 24, 1986
-OM WEST 2000 GNATUS CHAIR
K863008 · HME
Sds Dental, Inc.
Ophthalmic · 47d
Cleared Sep 24, 1986
DIGILAB MODULAR ONE-APPLANATION TONOMETER
K863217 · HKX
Bio-Rad
Ophthalmic · 35d
Cleared Sep 24, 1986
STC 909ZX POWER BASE
K863233 · ITI
The Stc Companies, Inc.
Physical Medicine · 34d
Cleared Sep 24, 1986
RAYLOR BONE IMPACTORS
K863415 · HAO
Cedar Surgical, Inc.
Neurology · 21d
Cleared Sep 24, 1986
RAYLOR MINI-PROBE
K863416 · HAO
Cedar Surgical, Inc.
Neurology · 21d
Cleared Sep 24, 1986
MODEL 352-01 SILICONE RUBBER ISOLATION SLEEVE
K863418 · DXY
Intermedics, Inc.
Cardiovascular · 21d
Cleared Sep 24, 1986
KASEY EYE SHIELD
K863474 · HOY
Kasey Enterprises, Inc.
Ophthalmic · 15d
Cleared Sep 24, 1986
RESPICENTRAL(TM)
K863538 · BZK
Dickstein, Shapiro & Morin
Anesthesiology · 13d
Cleared Sep 23, 1986
HOSPAL DIALYSATE FOR CAVHD
K861156 · KPO
Hospal Medical Corp.
Gastroenterology & Urology · 179d
Cleared Sep 23, 1986
FAGAN TEST MACHINE FOR INFANT INTELLIGENCE
K861304 · LQD
Infantest Corp.
Neurology · 169d
Cleared Sep 23, 1986
DENTIMEDIC DENTAL EMERGENCY KIT
K861681 · EMB
Dentimedic
Dental · 145d
Cleared Sep 23, 1986
BMRI SOFT TISSUE BIOPSY NEEDLE
K861959 · KNW
Bio-Medical Resources, Inc.
Gastroenterology & Urology · 126d
Cleared Sep 23, 1986
KOREAN GREEN CROSS SCALP VEIN SET
K862289 · FPA
Sturbridge Medical
General Hospital · 98d
Cleared Sep 23, 1986
MODEL PC-2 VOLUMETRIC INFUSION PUMP/CONTROLLER
K862295 · FRN
Imed Corp.
General Hospital · 98d
Cleared Sep 23, 1986
ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE
K862489 · KNT
Knight Medical, Inc.
Gastroenterology & Urology · 85d
Cleared Sep 23, 1986
HOLLISTER DRAIN TUBE ATTACHMENT
K862573 · KNT
Hollister, Inc.
Gastroenterology & Urology · 78d
Cleared Sep 23, 1986
NEPHROSTOMY DRAINAGE KIT (A-150)
K862580 · KNX
Advanced Clinical Products, Inc.
Gastroenterology & Urology · 78d
Cleared Sep 23, 1986
NEPHROSTOMY CONNECTING TUBE (A-50)
K862581 · KNX
Advanced Clinical Products, Inc.
Gastroenterology & Urology · 78d
Cleared Sep 23, 1986
SCIMED II-SM25 MEMBRANE OXYGENATOR SYSTEM
K862918 · DTZ
Scimed Life Systems, Inc.
Cardiovascular · 53d
Cleared Sep 23, 1986
MR620 DUAL SERVO HEATED ANAESTHESIA HUMIDIFIER
K862923 · BTT
Fisher & Paykel Allied Products , Ltd.
Anesthesiology · 53d
Cleared Sep 23, 1986
SPACELABS SERIES 90700 PATIENT MONITORS
K862951 · DPS
Spacelabs, Inc.
Cardiovascular · 49d
Cleared Sep 23, 1986
DISPOSABLE MIRROR
K862972
Quali-Med, Inc.
General & Plastic Surgery · 48d
Cleared Sep 23, 1986
MODIFIED PTCA GUIDING CATHETERS
K862975 · DQY
Cordis Corp.
Cardiovascular · 56d