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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
98473–98496 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 20, 1996
CELL RECOVERY SYSTEM
K960004 · FDX
Medical Device Technologies, Inc.
Gastroenterology & Urology · 78d
Cleared Mar 20, 1996
ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KIT
K960091 · LRM
Helix Diagnostics, Inc.
Immunology · 69d
Cleared Mar 20, 1996
KIS MT3
K960110 · DZE
The Implant Center of the Palm Beaches
Dental · 69d
Cleared Mar 20, 1996
DSDNA IMMUNOGLOBULIN EIA TEST SYSTEM
K960182 · LRM
Mardx Diagnostics, Inc.
Immunology · 64d
Cleared Mar 20, 1996
PERMAMESH-D HYDROXYLAPATITE MATRIX
K960354 · LZK
Ceramed Corp.
General & Plastic Surgery · 55d
Cleared Mar 20, 1996
PERMAMESH HYDROXYLAPATITE MATRIX
K960362 · LZK
Ceramed Corp.
General & Plastic Surgery · 55d
Cleared Mar 20, 1996
TRI-COUNT 20
K960471 · JPK
Hematronix, Inc.
Hematology · 48d
Cleared Mar 20, 1996
HALL MODULAR ACETABULAR REAMER SYSTEM
K960852 · HWE
Linvatec Corp.
Orthopedic · 19d
Cleared Mar 20, 1996
INTRADUCER PERITONEAL CATHETER 6FRX3, 9FRX3 1/2, 10FRX4, 12FRX8
K960883 · GCJ
Taut, Inc.
General & Plastic Surgery · 15d
Cleared Mar 19, 1996
SUDORMED SWEAT PATCH SPECIMENT CONTAINER (PHENCYCLIDINE)
K936240 · JKA
Sudormed, Inc.
Toxicology · 810d
Cleared Mar 19, 1996
STC DIAGNOSTICS PCP MICRO-PLATE EIA MODIFICATION
K940048 · DLJ
Solarcare Technologies Corp,Inc.
Toxicology · 804d
Cleared Mar 19, 1996
SLOAN STA-DRI PANT PROTECTOR
K945302 · LYU
Sloan Corp.
General Hospital · 567d
Cleared Mar 19, 1996
EIA KIT FOR THE DETECTION OF ANTI-MPO ANTIBODIES
K954062 · MOB
Scimedx Corp.
Immunology · 203d
Cleared Mar 19, 1996
EIA KIT FOR THE DETCTION OF ANTI-PR3 ANTIBODIES
K954105 · MOB
Scimedx Corp.
Immunology · 201d
Cleared Mar 19, 1996
O-PERM 30 A RIGID GAS PERMEABLE CONTACT LENS
K954124 · HQD
Optical Polymer Research, Inc.
Ophthalmic · 200d
Cleared Mar 19, 1996
DIGITAL IMAGING SYSTEM
K954159 · LLZ
Camtronics, Ltd.
Radiology · 196d
Cleared Mar 19, 1996
PACE SAVER LITTLE JUNIOR (MODIFICATION)
K954974 · INI
Burke Mobility Products
Physical Medicine · 146d
Cleared Mar 19, 1996
QUANTA LITE PR3
K955021 · MOB
Inova Diagnostics, Inc.
Immunology · 138d
Cleared Mar 19, 1996
QUANTA LITE MPO
K955022 · MOB
Inova Diagnostics, Inc.
Immunology · 138d
Cleared Mar 19, 1996
ONE STEP PREGNANCY HCG SERUN DILUENT REAGENT
K955353 · JHI
Tcpi, Inc.
Chemistry · 119d
Cleared Mar 19, 1996
TRI-COURT 20-T
K960005 · JPK
Hematronix, Inc.
Hematology · 77d
Cleared Mar 19, 1996
CALCOFLUOR WHITE STAIN KIT
K960090 · JTS
Remel Co.
Microbiology · 68d
Cleared Mar 19, 1996
BACTIDROP CALCOFLUOR WHITE
K960095 · JTS
Remel Co.
Microbiology · 68d
Cleared Mar 19, 1996
PLATFORM ONESTEP PREGNANCY HOME TEST
K960117 · LCX
Syntron Bioresearch, Inc.
Chemistry · 68d