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
154825–154848 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 29, 1983
OHIO GMS ABSORBER
K833452 · BSF
Airco/Ohio Medical Products
Anesthesiology · 67d
Cleared Nov 29, 1983
PERCUTANEOUS ENDOSCOPIC GASTROSCOPY
K833492 · KNT
American Endoscopy, Inc.
Gastroenterology & Urology · 53d
Cleared Nov 29, 1983
DISPOSABLE SYRINGES & NEEDLES
K833493 · FMF
Aldrich Chemical Co., Inc.
General Hospital · 53d
Cleared Nov 29, 1983
BUNN MICRO OXYGEN CONCENTRATOR
K833495 · CAW
Greene & Kellogg, Inc.
Anesthesiology · 53d
Cleared Nov 29, 1983
MAX 02 OXYGEN CONCENTRATOR
K833500 · CAW
Mountain Medical Equipment, Inc.
Anesthesiology · 55d
Cleared Nov 29, 1983
CAPD ULTRAVIOLET GERMICIDAL EXCHANGE
K833595 · FKX
Travenol Laboratories, S.A.
Gastroenterology & Urology · 48d
Cleared Nov 29, 1983
RENALLOY HEMASITE VASCULAR ACCESS SHUNT
K833622 · FIQ
Renal Systems, Inc.
Gastroenterology & Urology · 46d
Cleared Nov 29, 1983
OPHTHALMIC CAUTERY #6821-HOT-TEMP #'S
K833648 · HAM
Edward Weck, Inc.
General & Plastic Surgery · 43d
Cleared Nov 29, 1983
CLIP APPLYING FORCEPS
K833651 · HCI
Advanced Biosearch Assn.
Neurology · 41d
Cleared Nov 29, 1983
IV EXTENSION SET
K833659 · FPK
Dna Medical, Inc.
General Hospital · 42d
Cleared Nov 29, 1983
COAXIAL BALLOON URETHRAL DILATOR
K833690 · FAA
American Edwards Laboratories
Gastroenterology & Urology · 42d
Cleared Nov 29, 1983
FRASER HARLAKE DENTAL ANTI-POLUTION SYS
K833692 · CBN
Fraser Harlake, Inc.
Anesthesiology · 42d
Cleared Nov 29, 1983
MASSATOR-PEDIO
K833840 · ISA
Trileen, Inc.
Physical Medicine · 26d
Cleared Nov 29, 1983
CHILD'S WALKER
K833869 · ITJ
Kaye Products, Inc.
Physical Medicine · 21d
Cleared Nov 29, 1983
KNEE WALKER
K833870 · ION
Maddak, Inc.
Physical Medicine · 21d
Cleared Nov 29, 1983
TELEPHONIC RECEIVER R-10 EEG
K833880 · GYE
Pharmaquest Corp.
Radiology · 13d
Cleared Nov 28, 1983
MULTIPLE
K831204 · NAD
Derma-Lock Medical Corp.
General & Plastic Surgery · 229d
Cleared Nov 28, 1983
NEUROFLAX, EPK
K831990 · GZJ
Franks Electronics
Neurology · 160d
Cleared Nov 28, 1983
PDM SILOXANE PROSTHETIC CHIN IMPLANT
K832148 · FWP
Delaware Prosthetics, Inc.
General & Plastic Surgery · 146d
Cleared Nov 28, 1983
PDM SILOXANE PROSTHETIC OBTURATOR
K832149
Delaware Prosthetics, Inc.
General & Plastic Surgery · 146d
Cleared Nov 28, 1983
TOURNIQUET CUFF PRESSURE MONITOR #TCPM
K832272 · LDQ
Electromedics, Inc.
General & Plastic Surgery · 139d
Cleared Nov 28, 1983
PROGRAMED
K832349 · FRN
Intrabionic Co.
General Hospital · 133d
Cleared Nov 28, 1983
INTRABIONIC CO. - MICRO SYRINGE
K832350 · FRN
Intrabionic Co.
General Hospital · 133d
Cleared Nov 28, 1983
PROTECTIVE SLEEVE
K832380 · DYG
Vertex Medical Corp.
Cardiovascular · 132d