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
161449–161472 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 07, 1982
CAULK OPAQUER
K813357 · EBF
Dentsply Intl.
Dental · 41d
Cleared Jan 07, 1982
EYE CHARTS
K813376 · HOX
Abco Dealers, Inc.
Ophthalmic · 37d
Cleared Jan 07, 1982
DISPOSABLE NEONATAL VENTILATION CIRCUIT
K813384 · BZO
Intec.
Anesthesiology · 36d
Cleared Jan 07, 1982
INZOMA P
K813417 · EJT
J. Aderer, Inc.
Dental · 31d
Cleared Jan 07, 1982
INZOMA NP
K813418 · EJS
J. Aderer, Inc.
Dental · 31d
Cleared Jan 07, 1982
OXYCON
K813436 · CAW
Home Medical Mfg., Co., Inc.
Anesthesiology · 30d
Cleared Jan 07, 1982
POTTS-COURNAND STYLE NEEDLE
K813448 · GAA
Ocean Medical Products, Ltd.
General & Plastic Surgery · 27d
Cleared Jan 07, 1982
CHIBA SKINNY NEEDLE
K813460 · GAA
Ocean Medical Products, Ltd.
General & Plastic Surgery · 27d
Cleared Jan 07, 1982
DISPOSABLE TRANSDUCER
K813464 · DRS
Sorensen Research
Cardiovascular · 27d
Cleared Jan 07, 1982
4004 CONSTANT FLOW REGULATOR
K813466 · CAN
Safety Laboratories West
Anesthesiology · 27d
Cleared Jan 07, 1982
2002 ADJUSTABLE FLOW REGULATOR
K813467 · CAN
Safety Laboratories West
Anesthesiology · 27d
Cleared Jan 07, 1982
ACC-U-THERM TEMPERATURE MONITOR
K813468 · FLL
Diatek, Inc.
General Hospital · 27d
Cleared Jan 07, 1982
ARGYLE PEDIATRIC URINE COLLECTOR
K813479 · KNX
Sherwood Medical Co.
Gastroenterology & Urology · 37d
Cleared Jan 07, 1982
VERSION OF A CLOSED-FLOW SYS. CALORIC
K813490 · ETF
Thomas M. Foti, M.D.
Ear, Nose, Throat · 34d
Cleared Jan 07, 1982
MEDIFIX
K813498 · KRK
Burron Medical Products, Inc.
Cardiovascular · 24d
Cleared Jan 07, 1982
ACESSORY TO MODIFIED FREEDING JEJUNOSTO
K813504 · KOA
Midwest Metabolic Support Group
Gastroenterology & Urology · 23d
Cleared Jan 05, 1982
TM-CAPD
K812615 · KPP
Tri-Med, Inc.
Gastroenterology & Urology · 112d
Cleared Jan 05, 1982
RELAXATION TANK
K812724
Float-To-Relax, Inc.
Physical Medicine · 99d
Cleared Jan 05, 1982
ALVEOGRAF DURAPATITE(18-40 MESH)
K813257 · DZE
Sterling Drug, Inc.
Dental · 47d
Cleared Jan 05, 1982
CUATICO MYELOGRAPHY NEEDLES
K813367 · GAA
Dlp, Inc.
General & Plastic Surgery · 36d
Cleared Jan 05, 1982
DISPOSABLE CHIBA-TYPE NEEDLE
K813368 · GAA
Dlp, Inc.
General & Plastic Surgery · 36d
Cleared Jan 05, 1982
PS-ROUND SURG. DRAIN & CONNECTOR
K813377 · GCY
Pudenz-Schulte Medical Research Corp.
General & Plastic Surgery · 35d
Cleared Jan 05, 1982
BONDARY SINGLE-USE OR GOWN
K813390 · FYA
The Buckeye Cellulose Corp.
General Hospital · 33d
Cleared Jan 05, 1982
SCALPEL
K813422 · GDX
Abco Dealers, Inc.
General & Plastic Surgery · 29d