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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
142321–142344 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 25, 1986
PROMEDICOR
K863514 · FMI
Terra Marketing Assoc.
General Hospital · 16d
Cleared Sep 25, 1986
EASY-TEST LACTIC DEHYDROGENASE (LDH) # 67527/95
K863545 · CFJ
Em Diagnostic Systems, Inc.
Chemistry · 13d
Cleared Sep 25, 1986
DISSCAP 80E, 110E, 140E, 160E
K863592 · FJI
Hospal Medical Corp.
Gastroenterology & Urology · 10d
Cleared Sep 25, 1986
AMERICAN EDWARDS 4.0 MM ARTHROSCOPE
K863597 · HRX
American Edwards Laboratories
Orthopedic · 10d
Cleared Sep 25, 1986
KNIFE MAKER
K863616 · IDL
Surgipath Medical Industries, Inc.
Pathology · 9d
Cleared Sep 25, 1986
SCHULMAN DOUBLE UMBILICAL CORD CLAMP NO. 1000
K863645 · HFW
United Medical Systems, Inc.
Obstetrics & Gynecology · 7d
Cleared Sep 25, 1986
OPHTHALMIC SURGICAL SPECULUM
K863664 · HNC
Myocure, Inc.
Ophthalmic · 7d
Cleared Sep 25, 1986
THE ULTIMATE
K863665 · HNN
Myocure, Inc.
Ophthalmic · 7d
Cleared Sep 24, 1986
MODIFIED CARDIOCAP MONITOR
K862455 · DSK
Datex Division Instrumentarium Corp.
Cardiovascular · 89d
Cleared Sep 24, 1986
BUCHBINDER(TM) MULTIFLEX(TM) GUIDEWIRE
K862937 · DQX
Versaflex Delivery Systems, Inc.
Cardiovascular · 51d
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