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
129889–129912 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 03, 1989
VAX-T PELVIC TRACTION BELT
K894435 · ITH
Vat-Tech, Inc.
Physical Medicine · 14d
Cleared Aug 02, 1989
MEDTRONIC INTRAVASCULAR BLOOD GAS MONITORING
K891013 · CCC
Medtronic Vascular
Anesthesiology · 155d
Cleared Aug 02, 1989
CAPNOMAC II(TM) ANESTHESIA MULTIGAS MONITOR
K891076 · CCK
Datex Division Instrumentarium Corp.
Anesthesiology · 155d
Cleared Aug 02, 1989
BMS-2000 MOBILE EEG SYSTEM
K891405 · GYE
Buckman Co., Inc.
Neurology · 141d
Cleared Aug 02, 1989
BREATHING CIRCUIT BACTERIAL FILTERS
K892520 · CAH
Arbo Medical, Inc.
General Hospital · 113d
Cleared Aug 02, 1989
CANDELA UPC LASER PHOTOCOAGULATOR
K893630 · HQF
Candela Laser Corp.
Ophthalmic · 83d
Cleared Aug 02, 1989
SOFTWARE VERSION, D1.3 AND A1.3 FOR MAGNETOM
K893640 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 79d
Cleared Aug 02, 1989
QRSYSTEMS H.D. NUCLEAR IMAGING TABLE
K893826 · IYZ
Qrsystems, Inc.
Radiology · 70d
Cleared Aug 02, 1989
CYSTO APRONS IN VARIOUS SIZES
K893842 · LYU
Bemiss Jason Corp.
General Hospital · 70d
Cleared Aug 02, 1989
SERATEST ENA [SCL-70] KIT
K894411 · LKJ
Hemagen Diagnostics, Inc.
Immunology · 16d
Cleared Aug 02, 1989
RAICHEM(TM) SPIA(TM) IGM REAGENTS
K894417 · DFT
Reagents Applications, Inc.
Chemistry · 16d
Cleared Aug 02, 1989
RAICHEM(TM) SPIA(TM) IGA REAGENTS
K894418 · CZP
Reagents Applications, Inc.
Chemistry · 16d
Cleared Aug 01, 1989
O BUTMENT
K884296 · DZE
"O" Co., Inc.
Dental · 293d
Cleared Aug 01, 1989
PROCEDURE READY TRAYS
K884577 · FOZ
Professional Medical Services
General Hospital · 273d
Cleared Aug 01, 1989
CAVENDISH 460/680 ANESTHESIA MACHINE
K884802 · BSZ
Dentsply Intl.
Anesthesiology · 257d
Cleared Aug 01, 1989
LYPHOCHEK(R) IMMUNOASSAY CONTR SERUM (HUMAN) 1,2,3
K891475 · JJX
Bio-Rad
Chemistry · 138d
Cleared Aug 01, 1989
INTRAVISION(TM) ARTHROSCOPE SYSTEM (ADD'L APPLI.)
K892376 · HRX
Concept, Inc.
Orthopedic · 118d
Cleared Aug 01, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892782 · LYY
Chung Yang Rubber Works (M) Sdn. Bhd.
General Hospital · 112d
Cleared Aug 01, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892788 · LYY
Dawin Investments , Ltd.
General Hospital · 112d
Cleared Aug 01, 1989
STERIL-DERM TRANSPARENT WOUND DRESSING
K892837 · NAD
Biointerface Technologies, Inc.
General & Plastic Surgery · 105d
Cleared Aug 01, 1989
ACCUTOUCH PATIENT EXAM GLOVES
K892977 · LYY
Thai Medical Industries Co., Ltd.
General Hospital · 111d
Cleared Aug 01, 1989
LATEX EXAMINATION GLOVES
K893262 · LYY
S.C. Rubber Co., Ltd.
General Hospital · 106d
Cleared Aug 01, 1989
PHARMASEAL MEDI-VAC STERILE POST-OP AUTOTRANS. SYS
K893578 · CAC
Baxter Healthcare Corp
Anesthesiology · 84d
Cleared Aug 01, 1989
SILICONE BI-LUMEN IRRIGATION EMBOLECTOMY CATH.
K893680 · DXE
Cathlab Corp.
Cardiovascular · 77d