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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
102361–102384 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 14, 1995
ELASTOMERIC SLEEP APPLIANCE
K946112 · LQZ
Village Park Orthodontics
Dental · 181d
Cleared Jun 14, 1995
IMPLA-MED LOW MARGIN ABUTMENTS, SCREWDRIVER, POLISHING PROTECTOR
K946198 · DZE
Sterngold
Dental · 176d
Cleared Jun 14, 1995
INTRAOPERATIVE CORNEAL TOPOGRAPHY SYSTEM (I-CTS)
K950077 · MMQ
Par Vision Systems Corp.
Ophthalmic · 155d
Cleared Jun 14, 1995
TOTAL PROTEIN TEST (TPRO) ITEM NUMBER: XXXXX/R1. R2
K950234 · CEK
Emd Chemicals, Inc.
Chemistry · 152d
Cleared Jun 14, 1995
DISPOSABLE & REUSABLE BIPOLAR SUCTION COAGULATOR
K950375 · GEI
Boston Surgical Products, Inc.
General & Plastic Surgery · 134d
Cleared Jun 14, 1995
QUEST RETROGRADE CARDIPLEGIA CANNULA-RCCS
K951088 · DWF
Quest Medical, Inc.
Cardiovascular · 97d
Cleared Jun 14, 1995
KARL STORZ PUNCTURE, INJECTION, ENDOSCOPIC, VERESS NEEDLE
K951190 · HET
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 90d
Cleared Jun 14, 1995
MICROSURGE BIPOLAR GRASPERS
K951230 · GEI
Microsurge, Inc.
General & Plastic Surgery · 86d
Cleared Jun 14, 1995
OLYMPUS ARTHROSCOPY SYSTEM
K951354 · HRX
Olympus America, Inc.
Orthopedic · 82d
Cleared Jun 14, 1995
WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT
K951519 · FWL
Wells Johnson Co.
General & Plastic Surgery · 72d
Cleared Jun 14, 1995
PULSE*SPRAY INFUSION SYSTEM
K951602 · KRA
Angiodynamics, Div. E-Z-Em, Inc.
Cardiovascular · 92d
Cleared Jun 14, 1995
PALLIAG NF IV
K951789 · EJT
Degussa Corp.
Dental · 58d
Cleared Jun 14, 1995
MYOEXORCISER II FUAL
K951969 · HCC
Verimed Holdings, Inc.
Neurology · 48d
Cleared Jun 14, 1995
PRESSURIZER
K951988 · KZD
Promedic, Inc.
General Hospital · 48d
Cleared Jun 14, 1995
STORZ MICROSEAL DP8030 & DP8045 PHACOEMULSIFICATION NEEDLES
K952259 · HQC
Storz Instrument Co.
Ophthalmic · 30d
Cleared Jun 14, 1995
PRECISION LINK BLOOD GLUCOSE DATA MANAGEMENT SYSTEM
K952279 · CGA
Medisense, Inc.
Chemistry · 64d
Cleared Jun 14, 1995
WOUND CARE MANAGEMENT KITS
K952335 · LYY
Continental Medical Laboratories, Inc.
General Hospital · 27d
Cleared Jun 14, 1995
ELECTROSURGICAL DISPERSIVE ELECTRODE
K952577 · GEI
Medtrex, Inc.
General & Plastic Surgery · 9d
Cleared Jun 13, 1995
WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
K920186 · FIP
Better Water, Inc.
Gastroenterology & Urology · 1246d
Cleared Jun 13, 1995
MODEL 2500E/2500ER HYPERBARIC CHAMBER
K934164 · CBF
Sechrist Industries, Inc.
Anesthesiology · 655d
Cleared Jun 13, 1995
0.035 IN. WISE WIRE
K942927 · DQO
Boston Scientific Corp
Radiology · 356d
Cleared Jun 13, 1995
VIDAS LYME SCREEN II
K943812 · LSR
Biomerieux Vitek, Inc.
Microbiology · 312d
Cleared Jun 13, 1995
OLYMPUS LAPAROSCOPIC ULTRASOUND SYSTEM
K944017 · ITX
Olympus America, Inc.
Radiology · 301d
Cleared Jun 13, 1995
OLYMPUS NBD TUBES
K944912 · FGE
Olympus America, Inc.
Gastroenterology & Urology · 251d