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
143593–143616 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 10, 1986
SURGI-TIE LOOPS
K861161
Healthmed Corp.
General & Plastic Surgery · 74d
Cleared Jun 10, 1986
WELCH ALLYN TYMPANOMETER
K861516 · ETY
Welch Allyn, Inc.
Ear, Nose, Throat · 48d
Cleared Jun 10, 1986
SLIDE CULTURE U 'EIKEN'
K861631 · JXA
Syn-Kit, Inc.
Microbiology · 42d
Cleared Jun 10, 1986
WEIGHTED ACQUISITION MODULE
K861637 · IYX
Siemens Gammasonics, Inc.
Radiology · 41d
Cleared Jun 10, 1986
AUTOFLUOR V
K861978 · KTL
Technia Diagnostics , Ltd.
Immunology · 20d
Cleared Jun 10, 1986
PENICILLIN-STREPTOMYCIN-FUNGIZONE MIXTURE
K861997 · JSK
Hazleton Research Products, Inc.
Microbiology · 18d
Cleared Jun 10, 1986
MENTOR FLAT-SPAN
K862049 · LCJ
Mentor Corp.
General & Plastic Surgery · 12d
Cleared Jun 10, 1986
NONWOVEN SURGICAL DRAPE PACK
K862062 · KKX
East Texas Lighthouse For the Blind
General Hospital · 11d
Cleared Jun 09, 1986
LIFESTAT 100
K853561 · DXN
Physio-Control Corp.
Cardiovascular · 287d
Cleared Jun 09, 1986
ELECTRO-MYOGRAPHIC PERINEOMETER
K854193 · HIR
Verimed Holdings, Inc.
Gastroenterology & Urology · 237d
Cleared Jun 09, 1986
COLIN ELECTRONICS CO., LTD. STBP 680
K854481 · DXN
Colin Medical Instruments Corp.
Cardiovascular · 214d
Cleared Jun 09, 1986
70 ML RESERVOIR BAG AND ADMINISTRATION SETS
K860222 · FRN
Prn Services, Inc.
General Hospital · 138d
Cleared Jun 09, 1986
LENS SPECTACLE NON-CUSTOM (PRESCRIPTION)
K861162 · HQG
Efop
Ophthalmic · 73d
Cleared Jun 09, 1986
SUCTION SYSTEM
K861306 · GEA
Axiom Medical, Inc.
General & Plastic Surgery · 62d
Cleared Jun 09, 1986
PATIENTCARE 1000
K861324 · FRN
Criticare Technologies Corp.
General Hospital · 62d
Cleared Jun 09, 1986
SOF SET, MODELS 111 AND 112
K861436 · FRN
Pacesetter Systems
General Hospital · 53d
Cleared Jun 09, 1986
MULTILUMEN VIAPIC CENTRAL LINE CATHETER
K861510 · FOZ
Warner-Lambert Co.
General Hospital · 47d
Cleared Jun 09, 1986
SCHNEIDER-SHILEY WIRE TORQUER
K861606 · DQX
Shiley, Inc.
Cardiovascular · 41d
Cleared Jun 09, 1986
SCHNEIDER-SHILEY INFLATION SYRINGES
K861607 · MAV
Shiley, Inc.
Cardiovascular · 41d
Cleared Jun 09, 1986
SEIKO P-2 & SEIKO P-3 (SPECTACLE LENS)
K861684 · HQG
Seiko Optical Products of America, Inc.
Ophthalmic · 38d
Cleared Jun 09, 1986
(MODIFIED) OMNIFIT THREADED ACETABULAR COMPONENT
K861723 · KWA
Osteonics Corp.
Orthopedic · 34d
Cleared Jun 09, 1986
TEC PORTAMAX H.V. PULSED GALVANIC STIMULATOR
K861739 · IPF
J.A. Preston Corp.
Physical Medicine · 34d
Cleared Jun 09, 1986
SAPPHIRE KNIFE BLADE
K861744 · HNN
Keeler Instruments, Inc.
Ophthalmic · 34d
Cleared Jun 09, 1986
GIRARD SUNGLASSES (NON-PRESCRIPTION)
K861759 · HQG
H. Girard S.A.
Ophthalmic · 34d