FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
73441–73464 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 19, 2002
BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117
K022660 · DRR
Biocheck, Inc.
Chemistry · 132d
Cleared Dec 19, 2002
COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SUTURE
K022715 · GAM
Ethicon, Inc.
General & Plastic Surgery · 126d
Cleared Dec 19, 2002
PHILIPS EASYVISION WORKSTATION RELEASE 6
K023137 · LLZ
Philips Medical Systems North America...
Radiology · 90d
Cleared Dec 19, 2002
ECHO SOUNDER, ES-102EX
K023143 · KNG
Koven Technology, Inc.
Radiology · 90d
Cleared Dec 19, 2002
MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110
K023264 · FRN
Alaris Medical Systems, Inc.
General Hospital · 80d
Cleared Dec 19, 2002
OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM AND ITS ASSOCIATED ACCESSORIES
K023280 · GEI
Olympus Optical Co., Ltd.
General & Plastic Surgery · 79d
Cleared Dec 19, 2002
STEELEX STERNUM SET
K023411 · GAQ
Aesculap, Inc.
General & Plastic Surgery · 69d
Cleared Dec 19, 2002
BIOPSY SITE TISSUE MARKER DEVICE
K023450 · NEU
Promex, Inc.
General & Plastic Surgery · 65d
Cleared Dec 19, 2002
MAS CARDIOIMMUNE TL LOW LEVEL LIQUID ASSAYED CARDIAC MARKER CONTROL, DADE...
K023669 · JJY
Medical Analysis Systems, Inc.
Chemistry · 49d
Cleared Dec 19, 2002
NORIAN XR CALCIUM PHOSPHATE BONE VOID FILLER
K023862 · MQV
Synthes (Usa)
Orthopedic · 29d
Cleared Dec 19, 2002
SISS REPROCESSED HOT BIOPSY FORCEPS, LAPAROSCOPIC, ENDOSCOPIC AND...
K024011 · NLU
Surgical Instruments Service and...
Gastroenterology & Urology · 15d
Cleared Dec 19, 2002
COBAS INTEGRA CREATININE PLUS VER.2 ASSAY
K024098 · JFY
Roche Diagnostics Corp.
Chemistry · 7d
Cleared Dec 18, 2002
ANTI-SNORING DEVICE OR ASD
K011723 · LRK
Pi Medical
Dental · 562d
Cleared Dec 18, 2002
DFA RESPIRATORY VIRUS SCREENING & ID KIT
K022713 · GNW
Diagnostic Hybrids, Inc.
Microbiology · 126d
Cleared Dec 18, 2002
AUTOSTAT II ANTI-B-2 GLYCOPROTEIN-I IGM ELISA
K022944 · MSV
Hycor Biomedical, Inc.
Immunology · 104d
Cleared Dec 18, 2002
AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGG ELISA
K022945 · MSV
Hycor Biomedical, Inc.
Immunology · 104d
Cleared Dec 18, 2002
LAPARETTE, MODEL LAP J L S H N
K022979 · KNF
Instruments Medicaux G.B., Inc.
Obstetrics & Gynecology · 100d
Cleared Dec 18, 2002
ACE VERSANAIL
K023115 · HSB
DePuy Orthopaedics, Inc.
Orthopedic · 90d
Cleared Dec 18, 2002
BI-CORTICAL BIO POST AND WASHER, MODEL AR-1367B
K023119 · HTN
Arthrex, Inc.
Orthopedic · 90d
Cleared Dec 18, 2002
COALESCENT U-CLIP- AND ACCESSORIES
K023125 · NJU
Coalescent Surgical
General & Plastic Surgery · 90d
Cleared Dec 18, 2002
ANDREWS INTRODUCER, MODEL ASI01
K023173 · MDM
Andrews Surgical Innovations, Ltd.
General & Plastic Surgery · 86d
Cleared Dec 18, 2002
PURITAN BENNETT DATAFLOW DATA MANAGEMENT SOFTWARE
K023225 · BZG
Puritan Bennett Corp.
Anesthesiology · 82d
Cleared Dec 18, 2002
TERUMO SYRINGE WITH/WITHOUT NEEDLE
K023271 · FMF
Terumo Medical Corp.
General Hospital · 78d
Cleared Dec 18, 2002
GROSHONG NXT DUAL LUMEN PICC CATHETERS
K023374 · LJS
C.R. Bard, Inc.
General Hospital · 71d