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
175081–175104 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 03, 1976
REAGENT, LYOPHILIZED ANTI-STREPTOLYSIN O
K760096 · GTQ
Gamma Biologicals, Inc.
Microbiology · 50d
Cleared Aug 03, 1976
FEBRILE ANTIGENS & CONTROL SERUMS
K760097 · GSZ
Gamma Biologicals, Inc.
Microbiology · 50d
Cleared Aug 03, 1976
REAGENT, VDRL
K760098 · GMT
Gamma Biologicals, Inc.
Microbiology · 50d
Cleared Aug 03, 1976
NDC#12739-0011-1 C-ZYME GOT
K760193 · CIT
Coulter Electronics, Inc.
Chemistry · 28d
Cleared Aug 03, 1976
NDC#12739-0010-1 C-ZYME GPT
K760194 · CKA
Coulter Electronics, Inc.
Chemistry · 28d
Cleared Aug 03, 1976
REAGENT, TRIGLY. C-ZYME NDC#12739-0017-1
K760195 · CDT
Coulter Electronics, Inc.
Chemistry · 28d
Cleared Aug 03, 1976
ASSAY, AMPHET. NDC#11711-0127-1 COULTER
K760196 · DKZ
Coulter Electronics, Inc.
Toxicology · 28d
Cleared Aug 03, 1976
TEST, DETECTION, ANTINUCLEAR ANTIBODIES
K760206 · DHN
Intl. Diagnostic Technology
Immunology · 25d
Cleared Aug 03, 1976
CANNULAE, PLASTIC DISPOSABLE NASAL
K760218 · CAT
Manner Medical Products
Anesthesiology · 22d
Cleared Aug 03, 1976
MASKA, OXYGEN VINYL D-SP. SINGLE USE
K760219 · BYG
Manner Medical Products
Anesthesiology · 22d
Cleared Aug 03, 1976
TUBING, SINGLE USE OXYGEN SUPPLY
K760220 · BYX
Manner Medical Products
Anesthesiology · 22d
Cleared Aug 03, 1976
I.P.P.B., DIS. W/MANIFOLD/NEBULIZER
K760221 · CBO
Manner Medical Products
Anesthesiology · 22d
Cleared Aug 03, 1976
GLOVES, STERILE LATEX SURGEON'S
K760243 · KGO
Travenol Laboratories, S.A.
General Hospital · 18d
Cleared Aug 03, 1976
RADIOASSY KIT, 3H-FOLATE
K760262 · CGN
Diamond Shamrock Corp.
Chemistry · 13d
Cleared Aug 03, 1976
ACTIN, ACTIVATED CEPHALOPLASTIN REAGENT
K760318 · GFO
Dade, Baxter Travenol Diagnostics, Inc.
Hematology · 8d
Cleared Aug 03, 1976
CHAIR, DENTAL OPERATIVE
K760321
The S. S. White Co.
Dental · 8d
Cleared Aug 03, 1976
CHAIR, ATTACHED INSTRUMENT DEL. SYS.
K760322 · KLC
The S. S. White Co.
Dental · 8d
Cleared Aug 03, 1976
X-RAY UNIT, DENTAL DIAGNOSTIC
K760323 · EAP
The S. S. White Co.
Radiology · 8d
Cleared Aug 03, 1976
BONDING AGENT, PRESTIGE
K760324 · KLE
Lee Pharmaceuticals
Dental · 8d
Cleared Aug 03, 1976
SURGICAL INSTRUMENTS, ORTHOPEDIC
K760325 · HTX
Depuy, Inc.
Orthopedic · 8d
Cleared Jul 26, 1976
ARCH SUPPORT (ARCH AID)
K760001
Zimmer, Inc.
Physical Medicine · 61d
Cleared Jul 26, 1976
KNEE AID
K760002 · IQI
Zimmer, Inc.
Physical Medicine · 61d
Cleared Jul 26, 1976
CAST MATERIAL (WICKET STOCKINETTE)
K760003 · ITG
Zimmer, Inc.
Physical Medicine · 61d
Cleared Jul 26, 1976
COLORIMETRIC DETERMINATION (SGOT/SGPT)
K760010 · CIT
The Dow Chemical Co.
Chemistry · 46d