FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
76921–76944 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 16, 2002
SEMPERMED SUPREME, SIZES 5.5, 6, 6.5, 7, 7.5, 8, 8.5, AND 9
K013560 · KGO
Semperit Technische Produkte Gesellshaft
General Hospital · 82d
Cleared Jan 16, 2002
NEXUS 2 CLEAR
K013609 · EMA
Sybron Dental Specialties, Inc.
Dental · 77d
Cleared Jan 16, 2002
REVOLUTION FORMULA 2
K013647 · EBF
Sybron Dental Specialties, Inc.
Dental · 72d
Cleared Jan 16, 2002
PLANMED SOPHIE & PLANMED SOPHIE CLASSIC
K013656 · IZH
Planmed OY
Radiology · 71d
Cleared Jan 16, 2002
HI-TOQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC...
K013833 · DQX
Guidant Corp.
Cardiovascular · 58d
Cleared Jan 16, 2002
KSEA CLEARVISION LENS IRRIGATION SYSTEM
K013838 · EOB
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 58d
Cleared Jan 16, 2002
HL168E
K014122 · DXN
Health & Life Co., Ltd.
Cardiovascular · 30d
Cleared Jan 16, 2002
NUMED COEFFICIENT PTV CATHETERS
K014124 · OMZ
NuMED, Inc.
Cardiovascular · 30d
Cleared Jan 16, 2002
MODIFICATION TO EBI OMEGA 21 SYSTEM
K014137 · MNH
Ebi, L.P.
Orthopedic · 30d
Cleared Jan 16, 2002
LOGIQBOOK
K014206 · IYO
General Electric Co.
Radiology · 26d
Cleared Jan 15, 2002
RANDOX CARBAMAZEPINE
K011648 · KLT
Randox Laboratories, Ltd.
Toxicology · 231d
Cleared Jan 15, 2002
RANDOX VALPROIC ACID
K011649 · LEG
Randox Laboratories, Ltd.
Toxicology · 231d
Cleared Jan 15, 2002
PASS SPINAL SYSTEM
K013442 · KWP
Encore Orthopedics, Inc.
Orthopedic · 90d
Cleared Jan 15, 2002
ISOBAR SPINAL SYSTEM
K013447 · KWP
Scien'Tx USA, Inc.
Orthopedic · 90d
Cleared Jan 15, 2002
PRISMASATE
K013448 · KPO
Gambro Renal Products
Gastroenterology & Urology · 90d
Cleared Jan 15, 2002
ACCENT
K013574 · LLZ
Confirma, Inc.
Radiology · 78d
Cleared Jan 15, 2002
STAT PROFILE PHOX BASIC ANALYZER
K013729 · CHL
Nova Biomedical Corp.
Chemistry · 67d
Cleared Jan 15, 2002
SYNCHRON SYSTEMS PANCREATIC AMYLASE (PAM) REAGENT
K013978 · JFJ
Beckman Coulter, Inc.
Chemistry · 43d
Cleared Jan 15, 2002
SJM TAILOR ANNULOPLASTY RING MODEL TARP- (SIZE)
K014161 · KRH
St. Jude Medical, Inc.
Cardiovascular · 27d
Cleared Jan 15, 2002
MODIFICATION TO OPTIMUM CLEANING, DISINFECTING AND
K014162 · MRC
Lobob Laboratories, Inc.
Ophthalmic · 27d
Cleared Jan 15, 2002
M2376A DEVICELINK SYSTEM, MODEL M2376A
K014181 · MWI
Philips Medical Systems, Inc.
Cardiovascular · 26d
Cleared Jan 14, 2002
HEARTSTREAM/HEARTSTART FR2 AED ECG CABLE, MODELS M3860A, M3861A, M3840A, M3841A
K013425 · MKJ
Philips Medical Systems
Cardiovascular · 90d
Cleared Jan 14, 2002
ANTERIOR CERVICAL PLATE SYSTEM
K013439 · KWQ
Scien'Tx USA, Inc.
Orthopedic · 89d
Cleared Jan 14, 2002
NOTTA AMBULATORY RECORDER
K013450 · OLV
Stellate Systems
Neurology · 89d