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
148225–148248 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 28, 1985
SPACELABS-GENERAL SYSTEM LINK
K850627 · DQK
Spacelabs, Inc.
Cardiovascular · 98d
Cleared May 28, 1985
AIR COMPRESSOR
K850795 · BTI
Bear Medical Systems, Inc.
Anesthesiology · 110d
Cleared May 28, 1985
V.E.P. HIP -VARIABLE ENDO-PROSTHESIS
K850928 · KWL
Unitas Ent.
Orthopedic · 84d
Cleared May 28, 1985
EXPOSCOP MOBILE IMAGING SYSTEM
K851031 · JAA
Euro-Electronics, Inc.
Radiology · 77d
Cleared May 28, 1985
ZWEYMULLER CUP
K851213 · KWA
Allo Pro Corp.
Orthopedic · 63d
Cleared May 28, 1985
BFW VOICE GENERATOR
K851462 · BTO
Bfw Laboratories, Inc.
Anesthesiology · 46d
Cleared May 28, 1985
ALLERGENETICS IGE FAST TEST
K851512 · DHB
Allergenetics
Immunology · 43d
Cleared May 28, 1985
SLIT CAMERA MODEL 07-624
K851811 · IXH
Victoreen, Inc.
Radiology · 32d
Cleared May 24, 1985
XMC-S TUBESTAND XMT-S TABLE XMH-NTWALL
K842094 · IXQ
X-Ray Mfg. & Sales, Inc.
Radiology · 364d
Cleared May 24, 1985
COOK COUNTY HOSPITAL DRESSING CHANGE SET
K843206 · KDD
Geneva Laboratories, Inc.
General & Plastic Surgery · 282d
Cleared May 24, 1985
RMC ASPIRATOR - VACUUM PUMP
K850704
Reliance Medical Corp.
General & Plastic Surgery · 92d
Cleared May 24, 1985
OB-PH - PH TEST PAPER
K850858 · LNW
Uro Pharmaceuticals, Inc.
Chemistry · 84d
Cleared May 24, 1985
RADIAL IMMUNODIFFUSION PLATES ALPHA-2 MACROGLOBULI
K851282 · DEB
Cooper Biomedical, Inc.
Immunology · 53d
Cleared May 24, 1985
RADIAL IMMUNODIFFUSION PLATES TRANSFERRIN
K851287 · DDG
Cooper Biomedical, Inc.
Immunology · 53d
Cleared May 24, 1985
AMRESCO FLOW PAC SMA PHOSPHATE BUFFER CONCENTRATE
K851923 · CKA
Amresco, Inc.
Chemistry · 22d
Cleared May 24, 1985
TDX REA IRON/TIBC
K851930 · JMO
Abbott Laboratories
Chemistry · 22d
Cleared May 24, 1985
VARIAN AASP AUTOMATED SAMPLE PREP. SYSTEM
K851945 · KZR
Varian Assoc., Inc.
Chemistry · 21d
Cleared May 24, 1985
LKB-WALLAC 1230 ARCUS FLUOROMETER
K851984 · KHO
Lkb Instruments, Inc.
Chemistry · 17d
Cleared May 23, 1985
TELEDYNE DENSCO DRY TIPS SALIVA ABSORB-
K843539 · EFN
Molnlycke A/S Hospital Products
Dental · 258d
Cleared May 23, 1985
RENAFLO HEMOCONCENTRATOR
K844790 · KDI
Renal Systems, Inc.
Gastroenterology & Urology · 164d
Cleared May 23, 1985
TRANSPORT INCUBATOR 185
K850496 · FPL
Airborne Life Support Systems, Inc.
General Hospital · 104d
Cleared May 23, 1985
DISPOSABLE UROSTOMY POUCH
K850750 · EXB
Biolog, Inc.
Gastroenterology & Urology · 87d
Cleared May 23, 1985
DISPOS. DRAINABEL POUCH FOR ILEOSTOMY/COLOSTOMY
K850751 · EXB
Biolog, Inc.
Gastroenterology & Urology · 87d
Cleared May 23, 1985
COMPUTER INTERFACE - BIOFEEDBACK
K850759 · HCC
M.O.E Electronics Research & Prod.
Neurology · 87d