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

Filters: Cleared only ×
175,820 results
130489–130512 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Aug 01, 1989
LATEX EXAM GLOVES(MFG: LINGSHUN INDUSCOMM LTD LIAB
K893918 · LYY
P.C. Commercial, Inc.
General Hospital · 77d
Cleared Aug 01, 1989
MODIFIED DECANNULATION STOPPER
K894050 · JOH
Premier Medical
Anesthesiology · 55d
Cleared Aug 01, 1989
PATIENT EXAMINATION GLOVES
K894192 · LYY
Royal Pacific Intl. Trade, Inc.
General Hospital · 50d
Cleared Aug 01, 1989
LYPHOCHEK IMMUNOASSAY PLUS CONTROL SERUM
K894252 · JJY
Bio-Rad
Immunology · 42d
Cleared Aug 01, 1989
LAWANA PATIENT EXAMINATION GLOVES
K894307 · LYY
Viri Imports, Inc.
General Hospital · 39d
Cleared Aug 01, 1989
RAICHEM(TM) SPIA(TM) IGG REAGENTS
K894416 · KTO
Reagents Applications, Inc.
Chemistry · 15d
Cleared Jul 31, 1989
PROSTATIC URETHRO. BALLOON DILATATION CATHETER
K873295 · KOE
Medi-Tech, Inc.
Gastroenterology & Urology · 714d
Cleared Jul 31, 1989
E-MITT (CONDUCTIVE HAND COVER)
K883804 · EAT
The Institute For Technology Development
Dental · 327d
Cleared Jul 31, 1989
ACUSON S328 TRANSDUCER FOR FETAL CARDIAC PULSED
K890275 · IYO
Acuson Corp.
Radiology · 194d
Cleared Jul 31, 1989
VINYL EXAMINATION GLOVES (MFG. SALZGITTER MOREX)
K890968 · LYZ
Interpro Intl., Inc.
General Hospital · 154d