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
147193–147216 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 09, 1985
EXTERNAL FIXATION SYSTEM(CAT. # SERIAS 5129)
K852397 · JEC
Howmedica Corp.
Orthopedic · 64d
Cleared Aug 09, 1985
TOTAL CPM
K852399 · BXB
Invacare Corp.
Physical Medicine · 64d
Cleared Aug 09, 1985
PULMONARY VEIN CLAMP
K852479 · DXC
None
Cardiovascular · 59d
Cleared Aug 09, 1985
CO2 FOR ARTHROSCOPY
K852592 · HRX
The Anspach Effort, Inc.
Orthopedic · 51d
Cleared Aug 09, 1985
MULTIPLE(HEMORX) IF APPROVED BY TRADEMARK OFFICE
K852679 · LKX
J. & Jp., Inc.
Gastroenterology & Urology · 45d
Cleared Aug 09, 1985
URETERAL DILATOR/SHEATH SET
K852793 · EZN
American Edwards Laboratories
Gastroenterology & Urology · 39d
Cleared Aug 09, 1985
CONTACT CONDUCTIVE ADHESIVE GEL COMPOSITION
K852956 · GYB
Parker Laboratories, Inc.
Neurology · 29d
Cleared Aug 09, 1985
PROTECTIVE PAD FOR INCONTINENCE
K853079 · EYQ
I.C.D. Industries, Inc.
Gastroenterology & Urology · 17d
Cleared Aug 09, 1985
SPECTACLE PRESCRIPTION LENSES
K853110 · HQG
Ancie Laboratories
Ophthalmic · 16d
Cleared Aug 09, 1985
VISITEC 2 MICRON FLUID FILTER
K853135 · HQE
Visitec Co.
Ophthalmic · 14d
Cleared Aug 08, 1985
CHLAMYDIA
K843654 · GPW
Institute Virion , Ltd.
Microbiology · 325d
Cleared Aug 08, 1985
Q-FEVER
K843672 · GPS
Institute Virion , Ltd.
Microbiology · 325d
Cleared Aug 08, 1985
PFEIFFER PUMP
K851525 · CCQ
Ing. Erich Pfeiffer GmbH & Co. Kg.
Anesthesiology · 114d
Cleared Aug 08, 1985
OR TUBE RESTRAINT
K851874 · CBH
Kinetic Concepts, Inc.
Anesthesiology · 101d
Cleared Aug 08, 1985
AMSCO URO-ENDO MOBILE TABLE
K852127 · KQS
American Sterilizer Co.
Gastroenterology & Urology · 85d
Cleared Aug 08, 1985
PERCUTANEOUS PIGTAIL SUPRAPUBLIC CATHETER SET
K852287 · KOB
Cook Ob/Gyn
Gastroenterology & Urology · 71d
Cleared Aug 08, 1985
UNI-PLATE
K852643
Medical Specialties Laboratories
Hematology · 48d
Cleared Aug 08, 1985
SUNGLASSES
K852773 · HQY
Pony Industries Co., Ltd.
Ophthalmic · 44d
Cleared Aug 08, 1985
CORPAK ENTERAL SOL ADM PUMP SET W/ SCREW
K852792 · KNT
Corpak Co.
Gastroenterology & Urology · 38d
Cleared Aug 08, 1985
SUNNY SUN MAGNIFYING GLASSES
K852830 · HQY
Sunny Optical Co., Ltd.
Ophthalmic · 37d
Cleared Aug 08, 1985
ORTHO HEMATOLOGY CONT 14 NORMAL, 14 ABNORMAL H & L
K852834
Ortho Diagnostic Systems, Inc.
Hematology · 37d
Cleared Aug 08, 1985
PRECISION - COSMET CAPSULE COUPEUR
K852934 · HNY
Precision-Cosmet Co., Inc.
Ophthalmic · 30d
Cleared Aug 08, 1985
MAYFIELD DISPOSABLE SKULL PINS
K853066 · HAX
Codman & Shurtleff, Inc.
Neurology · 20d
Cleared Aug 07, 1985
SHARPLAN 1040 CO/2 SURGICAL LASER
K850628 · GEX
Laser Industries , Ltd.
General & Plastic Surgery · 169d