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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
141673–141696 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 19, 1986
EFTEKHAR RECHANNELIZATION DRILL GUIDE
K864314 · HSZ
The Anspach Effort, Inc.
Orthopedic · 16d
Cleared Nov 19, 1986
DR7700 OPERATING TABLE
K864325 · FQO
Koken Mfg Company, Inc.
General & Plastic Surgery · 16d
Cleared Nov 19, 1986
SECONDARY SET LOCK
K864338 · FPA
Travenol Laboratories, S.A.
General Hospital · 15d
Cleared Nov 19, 1986
LUTEX HEADLIGHT SYSTEMS
K864380 · FST
Luxtec Corp.
General & Plastic Surgery · 14d
Cleared Nov 19, 1986
LUXTEC RETRACTORS, LUXTEC SPECIALTY RETRACTORS
K864384 · GAD
Luxtec Corp.
General & Plastic Surgery · 14d
Cleared Nov 18, 1986
MODEL 8400 W/MODIFICATIONS (SPECTRUM 32)
K860801 · GWE
Cadwell Laboratories, Inc.
Neurology · 259d
Cleared Nov 18, 1986
FORTEC MI-100, BLOOD PRESSURE METER
K862200 · DSK
Fortec Electronic Corp./Nam Tai
Cardiovascular · 161d
Cleared Nov 18, 1986
MODEL 8 EEG PREAMPLIFIER
K863124 · GWQ
Micro Tronics Corp.
Neurology · 96d
Cleared Nov 18, 1986
MODIFIED SARNS OXYGENATOR SYSTEM
K863515 · DTZ
3M Health Care, Sarns
Cardiovascular · 69d
Cleared Nov 18, 1986
STOCKERT-SHILEY CAPS HLM INTERFACE
K863541 · DTQ
Shiley, Inc.
Cardiovascular · 68d
Cleared Nov 18, 1986
SARNS SAFETY LOOP
K863593 · DWD
3M Health Care, Sarns
Cardiovascular · 64d
Cleared Nov 18, 1986
MODEL (MB-700) BLOOD PRESSURE MONITOR
K863672 · DXN
Sharp Electronics Corp.
Cardiovascular · 76d
Cleared Nov 18, 1986
OPALUX VISIBLE LIGHT CURED ANTERIOR COMPOSITE
K863882 · EBF
Coe Laboratories, Inc.
Dental · 43d
Cleared Nov 18, 1986
MICROSCREEN I HEARING TESTER
K863979 · EWO
Microscreen
Ear, Nose, Throat · 35d
Cleared Nov 18, 1986
MODEL 320 TWO CHANNEL AUDIOMETER
K863984 · EWO
Virtual Corp.
Ear, Nose, Throat · 35d
Cleared Nov 18, 1986
BI-TEMP TEMPERATURE MONITOR
K863987
Respiratory Support Products, Inc.
Anesthesiology · 35d
Cleared Nov 18, 1986
DREAM DAM
K864096 · EIE
Dental Dam, Inc.
Dental · 28d
Cleared Nov 18, 1986
PROPHY CARE SOLUTION
K864215 · EJR
Imd, Inc.
Dental · 21d
Cleared Nov 18, 1986
MAX-I-PROBE PERIDONTAL/ENDODONTIC PROBE(TM) (MODI)
K864307 · EIC
Smith & Nephew, Inc.
Dental · 15d
Cleared Nov 17, 1986
NORELCO ELECTRONIC DIGITAL BP METER HC3030
K854279 · DXN
Philips Park
Cardiovascular · 389d
Cleared Nov 17, 1986
NORELCO DIGITAL BLOOD PRESSURE METER HC3001
K855048 · DXN
Philips Park
Cardiovascular · 335d
Cleared Nov 17, 1986
DOPPLEX, PULSED/CONTINUOUS WAVE DOPPOLER
K861023 · DPW
Diagnostic Electronics Corp.
Cardiovascular · 244d
Cleared Nov 17, 1986
BILATERAL IMPEDANCE PLETHYSMOGRAPH, BIP(TM)
K862714 · DSB
Electro-Diagnostic Instruments
Cardiovascular · 124d
Cleared Nov 17, 1986
VASOFLO-3 & EXTRAVASCULAR BLOOD FLOW PROBES
K862720 · DPW
Sonicaid, Inc.
Cardiovascular · 123d