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
134857–134880 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 01, 1988
MINIFUGE, MODEL 70
K882149 · GPG
Utah Bioresearch, Inc.
Hematology · 39d
Cleared Jul 01, 1988
BIOTROL TOTAL PROTEIN H.P.
K882189 · CEK
Biotrol, USA, Inc.
Chemistry · 38d
Cleared Jul 01, 1988
NIDEK ARK-2000
K882191 · HKO
Nidek, Inc.
Ophthalmic · 38d
Cleared Jul 01, 1988
SIMPLASTIN EXCEL S
K882214 · GJS
Organon Teknika Corp.
Hematology · 36d
Cleared Jul 01, 1988
CANON AUTOREFRACTOMETER R-20
K882287 · HKO
Canon USA, Inc.
Ophthalmic · 30d
Cleared Jul 01, 1988
EMIT CONVENIENCE PACK: TOBRAMYCIN ASSAY
K882294 · KLB
Syva Co.
Toxicology · 29d
Cleared Jul 01, 1988
TERUMO SENSIBEAD(TM) EIA ESTRADIOL KIT
K882343 · CHP
Terumo Medical Corp.
Chemistry · 24d
Cleared Jul 01, 1988
THIOGLYCOLLATE BROTH W/VITA. K & HEMIN - #T3007
K882495 · JSG
Lakewood Biochemical Co., Inc.
Microbiology · 15d
Cleared Jul 01, 1988
DISTOMETER
K882575 · HMM
Hagg-Streit Service, Inc.
Ophthalmic · 9d
Cleared Jun 30, 1988
VERRUCA-FREEZE(TM) CRYOTHERAPY DELIVERY SYSTEM
K881349 · GEH
Cryosurg, Inc.
General & Plastic Surgery · 92d
Cleared Jun 30, 1988
#557 DISPOSABLE CARDIOVASCULAR CLAMP
K881448 · DXC
Alpha Industries, Inc.
Cardiovascular · 85d
Cleared Jun 30, 1988
FIXATOR PIN (EXTERNAL)
K881511 · JDW
Orthopedic Systems, Inc.
Orthopedic · 80d
Cleared Jun 30, 1988
MEICOR X-RAY TUBE, MODELS MC1000, MC1500, MC2000
K882323 · ITY
Meicor, Inc.
Radiology · 24d
Cleared Jun 30, 1988
INSTRUMENT PROTECT-A-CAPS, AKA: TIP/INSTRU. GUARD
K882346 · FYF
Nordbye, Milchman, Barlage
General & Plastic Surgery · 23d
Cleared Jun 30, 1988
INFANT ELECTROSURGICAL DISPERSIVE ELECTRODE
K882421 · JOS
Dermacare Products, Inc.
General & Plastic Surgery · 17d
Cleared Jun 30, 1988
MASK, GAS, ANESTHETIC
K882434 · BSJ
Eastmed Enterprises, Inc.
Anesthesiology · 16d
Cleared Jun 30, 1988
ZINDRICK IM ROD INSTRUMENTS
K882443 · HSB
Buckman Co., Inc.
Orthopedic · 16d
Cleared Jun 29, 1988
CANNULA MODEL AR-6001
K880295 · HRX
Arthrex Arthroscopy Instruments, Inc.
Orthopedic · 156d
Cleared Jun 29, 1988
PROFORMA/PS TOTAL HIP SYSTEM
K880435 · JDI
Orthomet, Inc.
Orthopedic · 148d
Cleared Jun 29, 1988
(CHOICE) ALSO (KONDUM)
K880919 · HIS
Select Sources, Inc.
Obstetrics & Gynecology · 117d
Cleared Jun 29, 1988
CORIN MODULAR MOORE STEM
K881288 · LWJ
Orthopedic Systems, Inc.
Orthopedic · 93d
Cleared Jun 29, 1988
CORIN BIPOLAR PROSTHESIS
K881289 · KWY
Orthopedic Systems, Inc.
Orthopedic · 93d
Cleared Jun 29, 1988
ASTROSCAN 2100 MICROTITER PLATE READER
K881458 · JJQ
Astroscan , Ltd.
Hematology · 83d
Cleared Jun 29, 1988
KIRSCHNER (R) UNICONDYLAR-II KNEE SYSTEM
K882241 · HRY
Kirschner Medical Corp.
Orthopedic · 33d