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
167185–167208 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 26, 1980
ABCO SUCTION CATHETER & KITS W/GLOVE&CUP
K800234 · JOL
Abco Dealers, Inc.
General Hospital · 21d
Cleared Feb 26, 1980
ABCO CONNECTING TUBES PRECUT LENGTHS
K800235 · BYY
Abco Dealers, Inc.
General Hospital · 21d
Cleared Feb 26, 1980
MICRO MEDICAL DATA SYSTEM
K800241 · JQP
Micro/Tel., Inc.
Chemistry · 21d
Cleared Feb 26, 1980
EMIT -D.A.U. CANNABINOID URINE ASSAY
K800246 · LAT
Syva Co.
Toxicology · 21d
Cleared Feb 26, 1980
EMIT -D.A.U. CANNABINOID URINE CALIBS.
K800247 · DLJ
Syva Co.
Toxicology · 21d
Cleared Feb 26, 1980
AUDIONICS PB MAX HEARING AID
K800269 · ESD
Audionics Corp.
Ear, Nose, Throat · 20d
Cleared Feb 26, 1980
TRIEX-2 HOLLOW FIBER DIALYZER
K800270 · FJI
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 20d
Cleared Feb 26, 1980
COROMETRICS MEDICAL SYSTEMS 220 PH SYS.
K800271 · CHL
Transidyne General Corp.
Chemistry · 20d
Cleared Feb 26, 1980
RELY DEODERANT TAMPON
K800272 · HIL
Procter & Gamble Mfg. Co.
Obstetrics & Gynecology · 19d
Cleared Feb 26, 1980
OTICON MODEL E17VF EARETTE HEARING AID
K800283 · ESD
Oticon Corp.
Ear, Nose, Throat · 18d
Cleared Feb 26, 1980
THREE-WAY STOPCOCK EXTENSION SET 20-SL
K800284 · FMG
Abbott Laboratories
General Hospital · 18d
Cleared Feb 26, 1980
LDC SPECTROMONITOR III
K800289 · KIE
Laboratory Data Control
Toxicology · 15d
Cleared Feb 26, 1980
SPECIMEN COLLECTION PAN
K800309 · FMH
Sage Products, Inc.
General Hospital · 14d
Cleared Feb 26, 1980
OTICON MODEL E19VF EARETTE HEARING AID
K800316 · ESD
Oticon Corp.
Ear, Nose, Throat · 14d
Cleared Feb 26, 1980
VOLU-SOL EA-50 STAIN
K800322 · HZJ
Volu Sol Medical Industries
Pathology · 14d
Cleared Feb 26, 1980
VOLU-SOL HISTO./CYTO. STAIN MOD. #EA65
K800325 · HZJ
Volu Sol Medical Industries
Pathology · 14d
Cleared Feb 26, 1980
PHONIC EAR, MODEL 841L
K800340 · ESD
Hc Electronics
Ear, Nose, Throat · 11d
Cleared Feb 25, 1980
THEOPHYLLINE RIASSAY
K792062 · LCA
Ria Diagnostics
Toxicology · 133d
Cleared Feb 25, 1980
LDC CHROMATOGRAPHY ACCESSORY MODULE B
K800046 · KIE
Laboratory Data Control
Toxicology · 47d
Cleared Feb 22, 1980
VXTRA BACK PACK EKG ELECTRODE CAT. NO.
K792436 · DRX
Vxtra Corp.
Cardiovascular · 86d
Cleared Feb 22, 1980
UCA LOTION
K792490
Vanaray Laboratories, Inc.
Neurology · 81d
Cleared Feb 22, 1980
KALLESTAD FLORESCENT ANA/AMA/ASMA TEST
K792610 · DBL
Kallestad Laboratories, Inc.
Immunology · 66d
Cleared Feb 22, 1980
SMITH SUBTALAR PEG
K792670 · LXH
Dow Corning Wright
Orthopedic · 57d
Cleared Feb 22, 1980
BOOTS - OUTDOOR CARRIER FOR THE AMIGO
K800209 · ITI
Amigo Sales, Inc.
Physical Medicine · 21d