FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
131857–131880 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 26, 1989
DCD-1 (DIGITAL CONTOUR DETECT-RADIAT THERAPY) SYST
K883317 · IXI
S & S X-Ray Products, Inc.
Radiology · 264d
Cleared Apr 26, 1989
TYPE 9040 SYSTEM ATHENA
K884116 · DPS
S & W Medico Teknik
Cardiovascular · 208d
Cleared Apr 26, 1989
TYPE 9210 ECG SYSTEM ATHENA
K884117 · DRT
S & W Medico Teknik
Cardiovascular · 208d
Cleared Apr 26, 1989
ACROMED SPINAL ROD AND SPINAL HOOKS
K884163 · KWP
Buckman Co., Inc.
Orthopedic · 204d
Cleared Apr 26, 1989
CHOICE ALSO ORIENT SURGICAL GLOVES (STERILE)
K884328 · KGO
Select Sources, Inc.
General Hospital · 194d
Cleared Apr 26, 1989
OXYGEN CONCENTRATOR W/CONCENTRATION 3LPM 93% +/-3%
K884563 · CAW
Ivex Medical, Inc.
Anesthesiology · 177d
Cleared Apr 26, 1989
DIGISCAN
K884621 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 173d
Cleared Apr 26, 1989
EAR IRRIGATION SET 101 (EARIGATOR)
K884786 · KYZ
Physicians Supply Co.
General Hospital · 162d
Cleared Apr 26, 1989
AEROCHAMBER M.V.
K884803 · CAF
Monaghan Medical Corp.
Anesthesiology · 160d
Cleared Apr 26, 1989
CYTOGUIDE
K885020 · IZH
Philips Medical Systems North...
Radiology · 142d
Cleared Apr 26, 1989
INSU COOL
K885055 · LDQ
Dynex Trading Co.
General & Plastic Surgery · 140d
Cleared Apr 26, 1989
MICRO-STIM 200
K885190 · GZJ
Theri-Teck, Inc.
Neurology · 131d
Cleared Apr 26, 1989
MODEL L-2000 & L-500 CHIROPRACTIC TABLES
K885276 · INQ
Lesarn Mfg., Ltd.
Physical Medicine · 124d
Cleared Apr 26, 1989
QUIKREAD CHEM. ANALYZER & CHOLES. FOR WHOLE BLOOD
K890027 · CHH
Photec Diagnostics, Inc.
Chemistry · 112d
Cleared Apr 26, 1989
EXTENSION SETS WITH AND WITHOUT FILTERS
K890176 · FPA
Medical Support Systems
General Hospital · 134d
Cleared Apr 26, 1989
QUIKREAD CHEM. ANALYZER & CHOLES. FOR SERUM/PLASMA
K890267 · CHH
Photec Diagnostics, Inc.
Chemistry · 112d
Cleared Apr 26, 1989
GLOVES, PATIENT EXAMINATION
K890344 · JTN
Tomarc (M) Sdn Bhd
Microbiology · 93d
Cleared Apr 26, 1989
MODEL FT-100 INTRACRANIAL PRESSURE MONITOR
K890468 · GWM
Pearl Instruments Corp.
Neurology · 85d
Cleared Apr 26, 1989
LUXTEC ACO SERIES 4000 LIGHT SOURCE
K890716 · FCW
Luxtec Corp.
Gastroenterology & Urology · 72d
Cleared Apr 26, 1989
RIA-GNOST INSULIN
K890837 · CFP
Cambridge Medical Technology
Chemistry · 64d
Cleared Apr 26, 1989
ROYAL SHIELD LATEX EXAMINATION GLOVES(TM)
K890907 · LYY
Shield Gloves Manufacturer Sdn. Bhd....
General Hospital · 61d
Cleared Apr 26, 1989
ACA (R) DIGITOXIN CALIBRATOR
K891093 · DCJ
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 55d
Cleared Apr 26, 1989
ACA(R) DIGITOXIN (DGTX) METHOD
K891094 · LFM
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 55d
Cleared Apr 26, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891223 · LYY
Sin Super Holdings Sdn Bhd
General Hospital · 50d