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
134497–134520 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 19, 1988
MAMMO M
K882133 · IZH
Ziehm International, Inc.
Radiology · 122d
Cleared Sep 19, 1988
VARIAN CLINAC 1800S
K882326 · IYE
Varian Assoc., Inc.
Radiology · 105d
Cleared Sep 19, 1988
BARBITURATE ENZYME IMMUNOASSAY KIT
K882663 · DIS
General Diagnostics
Toxicology · 84d
Cleared Sep 19, 1988
MEVATRON, M 2 CLASS
K882729 · IYE
Siemens Medical Laboratories, Inc.
Radiology · 75d
Cleared Sep 19, 1988
A.C.I. TRACH TIE
K882891 · CBH
Auxiliary Care, Inc.
Anesthesiology · 70d
Cleared Sep 19, 1988
SYNCHRON CX4/CX5 CLINICAL CHEMISTRY ANALYZER REAGE
K883181 · CKA
Beckman Instruments, Inc.
Chemistry · 54d
Cleared Sep 19, 1988
EMIT (R) HVA NEGATIVE URINE
K883210 · DIF
Syva Co.
Toxicology · 52d
Cleared Sep 19, 1988
ALKPHOR(TM) SYSTEM, HUMAN SERUM ALKA PHOS ISOENZY
K883395 · JJT
Quantimetrix Medical Industries
Chemistry · 39d
Cleared Sep 19, 1988
HOSPITAL BED CLOTHING CRADLE
K883463 · FNL
Commercial Products & Engineering Co.
General Hospital · 35d
Cleared Sep 19, 1988
COULTER VISCOMETER II
K883503 · JJL
Coulter Electronics, Inc.
Chemistry · 33d
Cleared Sep 19, 1988
EXCELVIEW ILLUMINATOR
K883702 · IXC
Excel Medical Products, Inc.
Radiology · 20d
Cleared Sep 16, 1988
BARO-GRAF 24
K881297 · DRS
Instromedix, Inc.
Cardiovascular · 172d
Cleared Sep 16, 1988
PROCEDURE PACKS PRESS. MONITOR/ADMINISTRATION LINE
K882655 · DQO
Procedure Packs, Inc.
Cardiovascular · 79d
Cleared Sep 16, 1988
MRL OXIMETER
K882664 · DQA
Medical Research Laboratories, Inc.
Anesthesiology · 81d
Cleared Sep 16, 1988
PROCEDURE PACKS SOLUTION ADMINISTRATION SETS
K882716 · DQD
Procedure Packs, Inc.
Cardiovascular · 77d
Cleared Sep 16, 1988
SCIMED R30 SILICONE ASSIST RESERVOIR
K882720 · DTN
Scimed Life Systems, Inc.
Cardiovascular · 77d
Cleared Sep 16, 1988
ET HI-FLOW SOFT TIP/ET HI-FLOW/ENHANCED TORQUE ST
K882803 · DQY
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 71d
Cleared Sep 16, 1988
POLYSAFE IMPLANT. PACING LEADS W/TINED FIXA. TIP
K883016 · DTB
Cardiac Control Systems, Inc.
Cardiovascular · 59d
Cleared Sep 16, 1988
INTERSEPT*PREBYPASS FILTER
K883086 · KRJ
Medtronic Blood Systems, Inc.
Cardiovascular · 57d
Cleared Sep 16, 1988
PERFORMED CROWN (STAINLESS STEEL)
K883325 · ELZ
Whitecap Dental Co.
Dental · 42d
Cleared Sep 16, 1988
VITEK GRAM-NEGATIVE IDENTIFICATION CARD
K883558 · JSS
Vitek Systems, Inc.
Microbiology · 28d
Cleared Sep 16, 1988
INSTRUMENTARIUM ULF MR IMAGING SYSTEM VERSION 110
K883650 · LNH
Instrumentarium Corp.
Radiology · 18d
Cleared Sep 16, 1988
CHANG MEDIUM (ADDITIONAL INDICATIONS)
K883682 · KIT
Hana Biologics, Inc.
Pathology · 18d
Cleared Sep 15, 1988
COBE CENTRYSYSTEM HOLLOW FIBER DIALYZERS
K881811 · FJI
Cobe Laboratories, Inc.
Gastroenterology & Urology · 140d