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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
116305–116328 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 18, 1992
INTERTRON 4500, INTERTRON 5000, MASTERSTIM I-2
K921612 · LIH
Medstar, Inc.
Neurology · 137d
Cleared Aug 18, 1992
QUICK-CHECK II REAGENT STRIP
K921825 · CGA
Diagnostic Solutions, Inc.
Chemistry · 124d
Cleared Aug 18, 1992
REP SPE PLUS (PONCEAU S) SYSTEM
K922053 · CEF
Helena Laboratories
Chemistry · 106d
Cleared Aug 18, 1992
POLLY'S VITREOUS SCISSORS J-225-S
K922355 · HQE
O.R. Specialties, Inc.
Ophthalmic · 91d
Cleared Aug 18, 1992
ENDOSCOPIC CARPAL TUNNEL INSTRUMENTS
K922391 · HRX
Instratek, Inc.
Orthopedic · 90d
Cleared Aug 18, 1992
UNISTAT BILIRUBINOMETER MODELS 10310 AND 10311
K922770 · MQM
Leica, Inc.
Chemistry · 70d
Cleared Aug 18, 1992
KING DIAGNOSTIC TRIGLYCERIDES REAGENT
K922964 · CDT
King Diagnostics, Inc.
Chemistry · 60d
Cleared Aug 18, 1992
SIEMENS MODEL INFINITI 1001 B
K923379 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 40d
Cleared Aug 18, 1992
SIEMENS MODEL TRITON 3004 B
K923380 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 40d
Cleared Aug 18, 1992
OLYMPUS MAGNESIUM REAGENT
K923411 · JGJ
Olympus Corp.
Chemistry · 39d
Cleared Aug 18, 1992
OLYMPUS INORGANIC PHOSPHORUS REAGENT
K923564 · CEO
Olympus Corp.
Chemistry · 32d
Cleared Aug 18, 1992
OLYMPUS DIRECT BILIRUBIN REAGENT
K923608 · CIG
Olympus Corp.
Chemistry · 34d
Cleared Aug 17, 1992
NEW EXTRUSION VENDOR FOR POLYURETHANE TUBING
K914489 · DTB
Telectronics Pacing Systems, Inc.
Cardiovascular · 314d
Cleared Aug 17, 1992
SCIMED VIPER CATHETER
K915347 · LIT
Scimed
Cardiovascular · 265d
Cleared Aug 17, 1992
NOVA GAUZE(R) DISPOSABLE NONWOVEN SPONGES, STERILE
K915530 · HAX
American Threshold Industries, Inc.
Neurology · 251d
Cleared Aug 17, 1992
E.R. SUTURE TRAY, STERILE, DISPOSABLE
K920518 · KKX
Trinity Laboratories, Inc.
General Hospital · 195d
Cleared Aug 17, 1992
MODIFICATION COLUMNMATE
K920820 · LCP
Helena Laboratories
Hematology · 186d
Cleared Aug 17, 1992
CATHETER CHOLANGIOGRAPHY
K921921 · GEI
Laparomed Corp.
General & Plastic Surgery · 116d
Cleared Aug 17, 1992
COULTER MH009
K922181 · GKZ
Coulter Electronics, Inc.
Hematology · 101d
Cleared Aug 17, 1992
MULTISPECT(TM) 3 TRIPLE DETECTOR CAMERA SYSTEM
K922372 · KPS
Siemens Gammasonics, Inc.
Radiology · 89d
Cleared Aug 17, 1992
MULTISPECT(TM) 2 DUAL DETECTOR CAMERA SYSTEM
K922373 · KPS
Siemens Gammasonics, Inc.
Radiology · 89d
Cleared Aug 17, 1992
COMFEEL WOUND DRESSING ORD
K922461 · KMF
Coloplast A/S
General & Plastic Surgery · 83d
Cleared Aug 17, 1992
COMFEEL WOUND DRESSING SD
K922466 · KMF
Coloplast A/S
General & Plastic Surgery · 83d
Cleared Aug 14, 1992
NASAL/ORAL 02 DELIVERY AND GAS SAMPLING DEVICE
K911970 · CCK
Nasorcap Ent., Inc.
Anesthesiology · 469d