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
170809–170832 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 14, 1978
CONCHANEOPAK A CARTRIDGE HUMIDIFIER
K780845 · BTT
Respiratory Care, Inc.
Anesthesiology · 83d
Cleared Aug 14, 1978
OP-SITE ADHESIVE DRAPES
K780853 · KKX
Acme United Corp.
General Hospital · 84d
Cleared Aug 14, 1978
BARRIER GYNECOLOGY PACK FABRIC 450
K780856 · KKX
Surgikos, Inc.
General Hospital · 82d
Cleared Aug 14, 1978
MODEL 290 OXYGEN RICH AIR SUPPLY UNIT
K780862 · CAW
The John Bunn Co.
Anesthesiology · 76d
Cleared Aug 14, 1978
CHEST ROLLS HOLDER
K780866 · FSE
Devon Industries, Inc.
General & Plastic Surgery · 76d
Cleared Aug 14, 1978
PAD HOLDER KIT
K780867 · FSE
Devon Industries, Inc.
General & Plastic Surgery · 76d
Cleared Aug 14, 1978
CHEST ROLLS
K780868 · FSE
Devon Industries, Inc.
General & Plastic Surgery · 76d
Cleared Aug 14, 1978
CELL CULTURE LINES
K780869 · KIR
Bioassay Systems Research Corp.
Toxicology · 76d
Cleared Aug 14, 1978
ENEMA BAG
K780877 · FCE
Abco Dealers, Inc.
Gastroenterology & Urology · 76d
Cleared Aug 14, 1978
DIGOXIN STANDARDS IN HUMAN SERUM
K780889 · DMP
Pcl-Ria, Inc.
Toxicology · 75d
Cleared Aug 14, 1978
LIMB COVER
K780905 · IPM
Hydro-Med Products, Inc.
Physical Medicine · 73d
Cleared Aug 14, 1978
IN VITRO TOBRAMYCIN RIA KIT
K780934 · KLB
Clinical Assays, Inc.
Microbiology · 67d
Cleared Aug 14, 1978
BIO-MONITOR AMIKACIN
K780949 · KLP
Monitor Science Corp.
Toxicology · 66d
Cleared Aug 14, 1978
BIO-MONITOR TOBRAMYCIN
K780950 · DID
Monitor Science Corp.
Toxicology · 66d
Cleared Aug 14, 1978
BIO-MONITOR GENTAMICIN
K780951 · DKD
Monitor Science Corp.
Toxicology · 66d
Cleared Aug 14, 1978
QUICKRATE REACTION RATE ANALYZER
K780972 · JJI
Olympus Corp.
Chemistry · 63d
Cleared Aug 14, 1978
ANTI-HUMAN LDL SERUM
K781015 · DFC
Icl Scientific
Immunology · 59d
Cleared Aug 14, 1978
C3PA (GBG) PROPERDIN FACTOR B
K781016 · JZH
Icl Scientific
Immunology · 59d
Cleared Aug 14, 1978
ANTI-HUMAN C1 INHIBITOR SERUM (GOAT)
K781017 · DBA
Icl Scientific
Immunology · 59d
Cleared Aug 14, 1978
SURG. GOWN & DRAPE, LOW LINT TREATMENT
K781019 · KKY
Kimberly-Clark Corp.
General & Plastic Surgery · 210d
Cleared Aug 14, 1978
ANTI-HUMAN CIQ SERUM
K781022 · DAK
Icl Scientific
Immunology · 56d
Cleared Aug 14, 1978
ALPHA-1-ACID GLYCOPROTEIN SERUM, ANTI-HU
K781023 · DEX
Icl Scientific
Immunology · 56d
Cleared Aug 14, 1978
CERUOPLASMIN SERUM ANTI-HUMAN
K781024 · DDB
Icl Scientific
Immunology · 56d
Cleared Aug 14, 1978
HYDRAULIC SUCTION BIOPSY PUMP MODEL 7MM
K781038 · KNW
Quinton, Inc.
Gastroenterology & Urology · 56d