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
76417–76440 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jan 14, 2002
INCARE ADVANCE
K013483 · KOD
Hollister, Inc.
Gastroenterology & Urology · 87d
Cleared Jan 14, 2002
KAVO POLYLUX II
K013500 · EBZ
Kavo America
Dental · 84d
Cleared Jan 14, 2002
84 CHANNEL EEG
K014146 · GWQ
Xltek
Neurology · 27d
Cleared Jan 14, 2002
80 CHANNEL EEG
K014147 · GWQ
Xltek
Neurology · 27d
Cleared Jan 14, 2002
MODIFICATION TO BRIDGE SELF-EXPANDING BILIARY STENT DELIVERY SYSTEM (BRIDGE SE)
K014205 · FGE
Medtronic Ave, Inc.
Gastroenterology & Urology · 24d
Cleared Jan 11, 2002
NUTRISAFE PUR ENTERAL FEEDING TUBE
K003311 · FPD
Vygon Corp.
Gastroenterology & Urology · 445d
Cleared Jan 11, 2002
SMARTMONITOR 2, MODEL 4000
K011597 · FLS
Respironics Georgia, Inc.
Anesthesiology · 232d
Cleared Jan 11, 2002
RANDOX DIGITOXIN
K012112 · LFM
Randox Laboratories, Ltd.
Toxicology · 189d
Cleared Jan 11, 2002
BODYFIX
K013391 · IYE
Medical Intelligence Medizintechnik GmbH
Radiology · 88d