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
135457–135480 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 29, 1988
HYPODERMIC NEEDLE SHEATH HOLDER
K882405 · FMJ
Ansr Ent., Inc.
General Hospital · 19d
Cleared Jun 28, 1988
RIGEL MODEL MULTICARE 409
K875160 · DRT
Rigel Medical Electronics, Inc.
Cardiovascular · 196d
Cleared Jun 28, 1988
ULTRAVIOLET LIGHT PROTECTVE EYEWERE
K880666 · HOY
Free Sun Intl. AB
Ophthalmic · 131d
Cleared Jun 28, 1988
SLC HARD LENS CLEANER
K880688 · LPN
Ocular Pharmaceuticals, Inc.
Ophthalmic · 127d
Cleared Jun 28, 1988
OMNISIL, VINYL POLYSILOXANE IMPRESSION MATERIAL
K881091 · ELW
Coe Laboratories, Inc.
Dental · 112d
Cleared Jun 28, 1988
MSI 3002 SERIES BED
K881963 · FNL
Med Service, Inc.
General Hospital · 49d
Cleared Jun 28, 1988
MSI 3003 SERIES BED
K881964 · FNJ
Med Service, Inc.
General Hospital · 49d
Cleared Jun 28, 1988
RETROJECT(TM) ANTI-AIDS SYRINGE W/RETRAC. NEEDLE
K881980 · FMF
Habley Medical Technology Corp.
General Hospital · 47d
Cleared Jun 28, 1988
HR-1000 W/SUFFIXES (B,C OR D)
K882184 · LMB
Eigen
Radiology · 35d
Cleared Jun 28, 1988
NEPHROSS I.Q. ALLEGO
K882213 · FJI
Organon Teknika Corp.
Gastroenterology & Urology · 33d