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
172753–172776 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 26, 1977
STETHOSCOPE
K771505 · DQD
Swartz Medical Equipment
Cardiovascular · 21d
Cleared Aug 26, 1977
STETHOSCOPE
K771506 · DQD
Swartz Medical Equipment
Cardiovascular · 21d
Cleared Aug 26, 1977
SPECIALIST ARM & LEG PROTECTOR
K771519 · FMP
Johnson & Johnson Professionals, Inc.
General Hospital · 18d
Cleared Aug 26, 1977
SPIROMETEO & LUNG EXERCISER, 4601
K771532 · BWF
Boehringer Laboratories
Anesthesiology · 16d
Cleared Aug 26, 1977
BIOTRON 18
K771534 · QJQ
Biotronics Corp.
Neurology · 16d
Cleared Aug 26, 1977
CLINICAL EMG MODEL 133
K771577 · HCC
Calnor of EL Paseo, Inc.
Neurology · 8d
Cleared Aug 26, 1977
STETHOSCOPE, NURSESCOPE TYPE
K771581 · DQD
Swartz Medical Equipment
Cardiovascular · 8d
Cleared Aug 26, 1977
WILL-CERAM W-3
K771596 · EJS
Williams Gold Refining Co., Inc.
Dental · 7d
Cleared Aug 26, 1977
PATELLA PROSTHESIS/TRAIL COMPONENT
K771598 · JWH
Depuy, Inc.
Orthopedic · 7d
Cleared Aug 25, 1977
HEMOX-ANALYZER
K771253 · CHL
3M Company
Chemistry · 45d
Cleared Aug 25, 1977
CEBTRIA DIGOXIN RIA
K771255 · DON
Union Carbide Corp.
Toxicology · 44d
Cleared Aug 25, 1977
125 I ALDOSTERONE RIA KIT
K771526 · CJM
Diagnostic Products Corp.
Toxicology · 17d
Cleared Aug 25, 1977
TEMP. CROWN ACRYLIC RESIN
K771530 · EBG
J. Palmero Sales Co., Inc.
Dental · 17d
Cleared Aug 25, 1977
DIGOXIN RIA KIT
K771533 · DNJ
G.D. Searle and Co.
Toxicology · 15d
Cleared Aug 25, 1977
FETAL MONITORING SYSTEM
K771541 · HGM
Air-Shields, Inc.
Obstetrics & Gynecology · 14d
Cleared Aug 25, 1977
VERSATOME
K771549 · IZF
Kermath Mfg. Corp.
Radiology · 13d
Cleared Aug 25, 1977
SPIRAL SCALP ELECTRODE, 14499A
K771553 · HGP
Hewlett-Packard Co.
Obstetrics & Gynecology · 13d
Cleared Aug 25, 1977
HEMA-TEK II SLIDE STAINER
K771559 · KPA
Miles Laboratories, Inc.
Hematology · 10d
Cleared Aug 25, 1977
AGGLUTINATING SERUM W135
K771562 · GTJ
Burroughs Wellcome Co.
Immunology · 10d
Cleared Aug 25, 1977
MOBILE X-RAY SYS. MODEL 43820A
K771571 · IZL
Hewlett-Packard Co.
Radiology · 10d
Cleared Aug 25, 1977
PLATELET CONTROLS NORMAL & ABNORMAL
K771588 · GJP
Dade, Baxter Travenol Diagnostics, Inc.
Hematology · 7d
Cleared Aug 25, 1977
HEARING AID MODEL 775
K771607 · ESD
Danavox, Inc.
Ear, Nose, Throat · 3d
Cleared Aug 22, 1977
FURNACE AUTOSAMPLER, MODEL 155
K770994 · DOP
Instrumentation Laboratory CO
Toxicology · 82d
Cleared Aug 22, 1977
FORMALIN BUFFER CONCENTRATE
K771201 · IGG
Central Labs. Assoc. MD Pathologists
Pathology · 48d