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
131713–131736 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 05, 1989
SKIN SCRUB KIT
K890570 · LRO
Kit Pak, Inc.
General & Plastic Surgery · 88d
Cleared May 05, 1989
ACCUTHERM PTS-200
K890575 · DWJ
Medical Repackers Co.
Cardiovascular · 88d
Cleared May 05, 1989
HYDRODENT ANTIPLAQUE SYSTEM
K890600 · EFS
Hydrodent Laboratories, Inc.
Dental · 88d
Cleared May 05, 1989
OROSPHERE PLUS
K890682 · EJJ
Jeneric/Pentron, Inc.
Dental · 85d
Cleared May 05, 1989
CIRCUIT BREATHING (W CONNECTOR, ADAPTER Y PIECE)
K890822 · BZO
Ventlab Corp.
Anesthesiology · 77d
Cleared May 05, 1989
ACCESSORY TO CLINICAL ELECTRONIC THERMOMETER
K890823 · FLL
Sheridan Catheter Corp.
General Hospital · 77d
Cleared May 05, 1989
LD1 ISOENZYME REAGENT KIT
K890996 · JGF
Trace Scientific , Ltd.
Chemistry · 67d
Cleared May 05, 1989
IQ ALBUMIN
K891375 · CIX
Bd Becton Dickinson Vacutainer...
Chemistry · 57d
Cleared May 05, 1989
DISPOSABLE THERMOPLASTIC ANESTH BREATHING CIRCUITS
K891479 · CAI
Anetec, Inc.
Anesthesiology · 50d
Cleared May 05, 1989
ANGIOTEC FMX-2220 SYSTEM
K891485 · LMB
Andros Analyzers, Inc.
Radiology · 49d
Cleared May 05, 1989
INTRAVASCULAR ADMINISTRATION SET
K891919 · FMI
Multi-Med, Inc.
General Hospital · 39d
Cleared May 05, 1989
ACTIDERM*-OPAQUE
K892232 · FRO
Convatec, A Division of E.R. Squibb &...
General & Plastic Surgery · 31d
Cleared May 05, 1989
MODERN (STERILE SURGEON'S GLOVES)
K892285 · KGO
Firestone Financial Corp.
General Hospital · 29d
Cleared May 05, 1989
KENDALL CURITY URINARY DRAINAGE BAGS
K892433 · KNX
The Kendal Co.
Gastroenterology & Urology · 25d
Cleared May 05, 1989
VITALOGRAPH-BREATHCO MONITOR
K892524 · CCJ
Vitalograph , Ltd.
Anesthesiology · 24d
Cleared May 05, 1989
NEUROSURGICAL DRILLS: STILLE, HUDSON
K892531 · HBG
Zinnanti Surgical Instruments, Inc.
Neurology · 24d
Cleared May 05, 1989
NEUROSURICAL RETRACTORS - VARIOUS TYPES
K892543 · GZT
Zinnanti Surgical Instruments, Inc.
Neurology · 24d
Cleared May 04, 1989
SELECTIVE RAPID UREA
K883641 · LYR
Remel Co.
Microbiology · 252d
Cleared May 04, 1989
ELECTRODE A.PH BLOOD GAS B.ELECTROLYTE SYSTEMS
K884267 · CHL
Alko Diagnostic Corp.
Chemistry · 205d
Cleared May 04, 1989
PERME-AID TRANSPARENT DRESSING, #11XX
K884791 · NAD
Nitto Denko Technical Corp.
General & Plastic Surgery · 170d
Cleared May 04, 1989
SURG-E-TROL SYSTEM I AND SYSTEM II
K890622 · HQE
Mentor O & O, Inc.
Ophthalmic · 86d
Cleared May 04, 1989
AUTO SUTURE DISPOSABLE SURGICAL TROCAR*
K890818 · FZT
United States Surgical, A Division of...
General & Plastic Surgery · 76d
Cleared May 04, 1989
PATIENT EXAMINATION GLOVES
K890872 · LYY
Unigloves , Ltd.
General Hospital · 69d
Cleared May 04, 1989
VINYL EXAMINATION GLOVES (MFG. SALZGITTER MOREX)
K890967 · LYZ
Amerimed US Corp.
General Hospital · 66d