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
78433–78456 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 10, 2001
GENZYME DIRECT-AMYLASE TEST REAGENT
K011843 · JFJ
Genzyme Corp.
Chemistry · 59d
Cleared Aug 10, 2001
HYDROTOWER ARTHROSCOPIC ADMINISTRATION TUBING SET, MODEL 7-460-05
K011928 · FPA
Northgate Technologies, Inc.
General Hospital · 51d
Cleared Aug 10, 2001
OLYMPUS SPRAY CATHETER PW-6C-1
K012073 · EOQ
The Olympus Optical Co.
Ear, Nose, Throat · 39d
Cleared Aug 10, 2001
KODAK RADIATION ONCOLOGY SOFTWARE/ FOR ACR SYSTEMS
K012155 · LLZ
Eastman Kodak Company
Radiology · 30d
Cleared Aug 10, 2001
DIGORA PCT
K012170 · MUH
Soredex Palodex Group OY
Radiology · 29d
Cleared Aug 10, 2001
MODIFICATIONS TO EUB-525 DIAGNOSTIC ULTRASOUND SCANNER
K012239 · IYN
Hitachi Medical Corp.
Radiology · 24d
Cleared Aug 10, 2001
CHASE CARDIOVASCULAR PATCH
K012248 · DXZ
Chase Medical, Inc.
Cardiovascular · 24d
Cleared Aug 10, 2001
SIMPLICITY EURO QD INFUSION SET
K012330 · FPA
Sterling Medivations, Inc.
General Hospital · 18d
Cleared Aug 10, 2001
BASIC, MODELS BASIC 1, BASIC 2, AND BASIC 3
K012369 · IYN
Atys Medical
Radiology · 15d
Cleared Aug 10, 2001
HISPEED X/I SMART GANTRY OPTION
K012385 · JAK
Ge Medical Systems, Inc.
Radiology · 14d
Cleared Aug 10, 2001
REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM
K012389 · KPR
Ge Medical Systems, Inc.
Radiology · 14d
Cleared Aug 09, 2001
INTRALASE 600C LASER KERATOME
K002890 · GEX
Intra Lase Corp.
General & Plastic Surgery · 328d
Cleared Aug 09, 2001
OSSTELL RESONANCE FREQUENCY ANALYZER
K003714 · EKX
Integration Diagnostics, Ltd.
Dental · 251d
Cleared Aug 09, 2001
XUB EXTERNAL ULTRASOUND
K010702 · IMI
Kmi Kolster Methods, Inc.
Physical Medicine · 154d
Cleared Aug 09, 2001
MUSCLE STIMULATOR SA-100
K010807 · IPF
Health@Fitness Technologies, Inc.
Physical Medicine · 146d
Cleared Aug 09, 2001
ETG-100 OPTICAL ENCEPHALOGRAPHY SYSTEM
K011320 · DQA
Hitachi Medical Systems America, Inc.
Anesthesiology · 100d
Cleared Aug 09, 2001
ENDOPATH NON-BLADED SOLID OBTURATOR TROCAR SYSTEM
K011538 · GCJ
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 83d
Cleared Aug 09, 2001
TRXF INTELLIGENT DOSING SYSTEM (IDS) -DOSING CALCULATOR SUITE
K011571 · NDC
The RX Files Corp.
General Hospital · 80d
Cleared Aug 09, 2001
BCT SYSTEM
K011665 · JPA
Dade Behring, Inc.
Hematology · 71d
Cleared Aug 09, 2001
ACON PCP ONE-STEP PHENCYCLIDINE TEST STRIP, ACON PCP ONE-STEP PHENCYCLIDINE...
K011730 · LCM
ACON Laboratories, Inc.
Toxicology · 65d
Cleared Aug 09, 2001
ADVANTAGE MARIJUANA (THC) AND COCAINE HOME DRUG TEST
K011962 · DIO
Advantage Diagnostics Corp.
Toxicology · 48d
Cleared Aug 09, 2001
SYNTHES LCP PROXIMAL TIBIA PLATE
K011978 · HRS
Synthes (Usa)
Orthopedic · 45d
Cleared Aug 09, 2001
GIBBONS STERILE TROCAR KITS
K012198 · FBQ
Gibbons Surgical Corp.
General & Plastic Surgery · 27d
Cleared Aug 09, 2001
MODIFICATION TO ACCU-CHEK INFORM METER
K012210 · NBW
Roche Diagnostics Corp.
Chemistry · 24d