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
151873–151896 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 26, 1984
REGULAR PETAL SOFT PLASTIC APPLICATOR
K842619 · HEB
Tambrands, Inc.
Obstetrics & Gynecology · 21d
Cleared Jul 26, 1984
STERELIS SEALING EQUIPMENT
K842631 · FLE
Sterelis Corp.
General Hospital · 20d
Cleared Jul 26, 1984
BEAR JET-150 VENTILATOR
K842688 · CBK
Bear Medical Systems, Inc.
Anesthesiology · 16d
Cleared Jul 26, 1984
LUNG ANALYZER CM-310
K842760 · BZC
Cybermedic, Inc.
Anesthesiology · 10d
Cleared Jul 26, 1984
AVATRON UNIVERSAL ADULT VOL. VENTILATOR
K842778 · BZO
Avatron, Inc.
Anesthesiology · 10d
Cleared Jul 25, 1984
UMBILICAL VESSEL CATHETER
K840339 · FOS
Catheter Technology Corp.
General Hospital · 182d
Cleared Jul 25, 1984
IVENT 302VC DUAL CONTROLLER
K842210 · LDR
Ivent Corp.
General Hospital · 51d
Cleared Jul 25, 1984
CLINITEK 10 SEMI-AUTO URINALYSIS SYS
K842238 · KQO
Miles Laboratories, Inc.
Chemistry · 50d
Cleared Jul 25, 1984
MTP E.V. INFUSION PUMP
K842263 · FRN
Ziehm International, Inc.
General Hospital · 48d
Cleared Jul 25, 1984
SR- MODEL 230
K842289 · FRN
Hirata Sangyo Co. USA, Inc.
General Hospital · 47d
Cleared Jul 25, 1984
CHEMISTRY ANALYZER, GEN. PURPOSE
K842311 · JJQ
Hml Inc/Biotechnology Transfer
Chemistry · 43d
Cleared Jul 25, 1984
SYVA IQ 190 DIGITAL PIPETTER DILUTER
K842390 · JQW
Syva Co.
Toxicology · 37d
Cleared Jul 25, 1984
AXIOM STABLE II CHOLESTEROL TEST
K842441 · CHH
Axiom, Inc.
Chemistry · 34d
Cleared Jul 25, 1984
SHERIDAN/ENDO-PAK
K842635 · BTR
Sheridan Catheter Corp.
Anesthesiology · 16d
Cleared Jul 25, 1984
HYDRO/BUBBLE BATH DEVICE 300
K842641 · ILJ
Heddernheimer Metallwarenfabrik GmbH
Physical Medicine · 15d
Cleared Jul 25, 1984
BALSAN 700
K842642 · ILJ
Heddernheimer Metallwarenfabrik GmbH
Physical Medicine · 15d
Cleared Jul 25, 1984
MASSAPED
K842643 · ILJ
Heddernheimer Metallwarenfabrik GmbH
Physical Medicine · 15d
Cleared Jul 25, 1984
STANDARD WHEELCHAIR
K842719 · IQC
Greene International Corp.
Physical Medicine · 12d
Cleared Jul 25, 1984
SAFRANIN, 1% W/V
K842920
E K Ind., Inc.
Pathology
Cleared Jul 23, 1984
MEDICAL RUBBER GLOVES-STERILE-SURGEONS
K831632 · KGO
Tagum Rubber Industries, Ltd.
General Hospital · 430d
Cleared Jul 23, 1984
SURG-A-STAT VASECTOMY TIP
K840370 · GET
Suncoast Medical Manufacturers, Inc.
General & Plastic Surgery · 178d
Cleared Jul 23, 1984
SURG-A-STAT LOOP TIP 15
K840375 · GEI
Suncoast Medical Manufacturers, Inc.
General & Plastic Surgery · 178d
Cleared Jul 23, 1984
SURG-A-STAT CARDIOVASCULAR TIP
K840377 · GEI
Suncoast Medical Manufacturers, Inc.
General & Plastic Surgery · 178d
Cleared Jul 23, 1984
SURG-A-STAT LOOP TIP 2
K840387 · GEI
Suncoast Medical Manufacturers, Inc.
General & Plastic Surgery · 175d