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
131257–131280 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 27, 1989
SENTINEL LATEX EXAMINATION GLOVES
K892007 · LYY
Yeu Jeng Industrial Co., Ltd.
General Hospital · 28d
Cleared Apr 27, 1989
PATIENT EXAMINATION GLOVE (LATEX)
K892008 · LYY
Mediglove Sdn. Bhd.
General Hospital · 28d
Cleared Apr 27, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892010 · LYY
Glovco Malaysia Sdn Bhd
General Hospital · 28d
Cleared Apr 27, 1989
RESPAKIT
K892053 · CAE
Protectical Health & Safety , Ltd.
Anesthesiology · 29d
Cleared Apr 27, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892135 · LYY
Archer Exports Private , Ltd.
General Hospital · 23d
Cleared Apr 27, 1989
SENTINEL LATEX EXAMINATION GLOVES
K892147 · LYY
Tai Feng Blinds Industry Co., Ltd.
General Hospital · 20d
Cleared Apr 27, 1989
PATIENT EXAM GLOVES (MFG. TOONG HON RUBBER IND.)
K892161 · LYY
Ing Chen Pacific Ent. , Ltd.
General Hospital · 22d
Cleared Apr 27, 1989
PATIENT EXAM GLOVES (MFG. BONANZA INDUSTRIAL CORP)
K892162 · LYY
Ing Chen Pacific Ent. , Ltd.
General Hospital · 22d
Cleared Apr 27, 1989
SLT CONTACT LASER SYSTEMS (NEUROSURGERY)
K892345 · GEX
Surgical Laser Technologies, Inc.
General & Plastic Surgery · 22d
Cleared Apr 26, 1989
MRI NEO-TRYP TRYPSIN RIA
K883011 · JNO
Microbiological Research Corp.
Chemistry · 281d
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