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
141697–141720 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 17, 1986
LASER SURGICAL ROD
K862815 · GEX
Lifestream Int'L, Inc.
General & Plastic Surgery · 116d
Cleared Nov 17, 1986
UNITED WOUND COVERING, PACKAGE OF 5
K863389 · FRO
United Medical
General & Plastic Surgery · 75d
Cleared Nov 17, 1986
LEUKOPLAST(R) POROUS AND SPORT TAPE
K864160 · KGX
Beiersdorf, Inc.
General & Plastic Surgery · 25d
Cleared Nov 17, 1986
MBK SURGEONS'(STERILE & NON-STERILE) SURG GLOVES
K864165 · KGO
Mbk Medical Gloves Co., Ltd.
General Hospital · 25d
Cleared Nov 17, 1986
GILBAUGH ASPIRATING BIOPSY SYRINGE/NEEDLE/GUN
K864193 · GDM
Gaw, Inc.
General & Plastic Surgery · 21d
Cleared Nov 17, 1986
SURGICAL SKIN MARKER
K864371 · FZZ
Myocure, Inc.
General & Plastic Surgery · 12d
Cleared Nov 17, 1986
LUXTEC LOUPES FOR SURGICAL VISION
K864386 · FSP
Luxtec Corp.
General & Plastic Surgery · 12d
Cleared Nov 14, 1986
FLOW GENERATOR FOR SLEEP APNEA, LDS 1500
K862448 · BZD
Life Design Systems, Inc.
Anesthesiology · 140d
Cleared Nov 14, 1986
CHESEBROUGH POND'S HYDROCOLLOID DRESSING
K862803 · FRO
Chesebrough-Pond'S U.S.A. Co.
General & Plastic Surgery · 115d
Cleared Nov 14, 1986
TENSOTAPE SURGICAL ADHESIVE TAPE
K863865
Smith & Nephew, Inc.
General & Plastic Surgery · 42d
Cleared Nov 14, 1986
MODEL Q55XT POWERED TREADMILL
K864013 · IOL
Quinton, Inc.
Physical Medicine · 30d
Cleared Nov 14, 1986
PUSH CUSH
K864108 · KIC
Medical Industries America, Inc.
Physical Medicine · 24d
Cleared Nov 14, 1986
C' AIRECUSH SEAT CUSHION
K864109 · KIC
Medical Industries America, Inc.
Physical Medicine · 24d
Cleared Nov 14, 1986
VOCAID, ELECTRONIC VOCAL AID
K864204 · ILQ
Texas Instruments, Inc.
Physical Medicine · 18d
Cleared Nov 13, 1986
ERYTHOCYTE CREATINE
K852767 · JLA
Panmed, Inc.
Hematology · 503d
Cleared Nov 13, 1986
LIFE-PORT IMPLANTABLE VASCULAR ACCESS
K853827 · LJT
Strato Medical Corp.
General Hospital · 426d
Cleared Nov 13, 1986
INTESTOPLANT
K862412 · LLD
Burron Medical Products, Inc.
General Hospital · 141d
Cleared Nov 13, 1986
BENZODIAZEPINES TOXICOLOGY CONTROL
K862418 · LAS
Utak Laboratories, Inc.
Toxicology · 141d
Cleared Nov 13, 1986
SERUM VANCOMYCIN TOXICOLOGY CONTROL
K862419 · LAS
Utak Laboratories, Inc.
Toxicology · 141d
Cleared Nov 13, 1986
SKIN PURE
K862799 · GYB
Nihon Kohden America, Inc.
Neurology · 114d
Cleared Nov 13, 1986
MODEL T-1 OXYGEN ANALYZER
K863158 · CCL
Chrysalis Systems, Inc.
Anesthesiology · 87d
Cleared Nov 13, 1986
Q101 DIAGNOSTIC SPIROMETER
K863300 · BYT
Quinton, Inc.
Anesthesiology · 80d
Cleared Nov 13, 1986
CYTOTECH TOXOPLASMA IGG ENZYME IMMUNOASSAY
K863363 · LGD
Cytotech, Inc.
Microbiology · 72d
Cleared Nov 13, 1986
RECOVER
K863401 · EBF
Scientific Pharmaceuticals, Inc.
Dental · 71d