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
77929–77952 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Aug 09, 2001
IMAGE-X SYSTEM
K012355 · EHD
Tg Group, Inc.
Radiology · 15d
Cleared Aug 09, 2001
LIFERAY WL CASSETTE, LIFERAY KW CASSETTE
K012373 · IXA
Ferrania S.P.A.
Radiology · 14d
Cleared Aug 08, 2001
ANSPACH EMAX DRILL SYSTEM
K011444 · HBC
The Anspach Effort, Inc.
Neurology · 89d
Cleared Aug 08, 2001
REJUVENIQUE MODEL #RJV10
K011935 · NFO
Salton, Inc.
Neurology · 48d
Cleared Aug 08, 2001
FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL SE-312
K012054 · DXN
Sein Electronics Co., Ltd.
Cardiovascular · 37d
Cleared Aug 08, 2001
MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATION
K012286 · LBS
Roche Diagnostics Corp.
Chemistry · 19d
Cleared Aug 07, 2001
LACTOSORB RAPIDFLAP
K003281 · JEY
Biomet, Inc.
Dental · 292d
Cleared Aug 07, 2001
INPULSE DENTAL LASER
K011423 · GEX
Incisive, LLC
General & Plastic Surgery · 90d
Cleared Aug 07, 2001
WUJIN #3 FEMORAL BONE PLATE
K011459 · HRS
Biopro, Inc.
Orthopedic · 88d