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
116497–116520 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 30, 1992
ENZIP URINARY MICROALBUMIN TEST
K922032 · JIR
Diagnostic Specialties
Chemistry · 90d
Cleared Jul 30, 1992
HP SONOS 100 CF ULTRASOUND IMAGING SYSTEM
K922184 · ITX
Hewlett-Packard Co.
Radiology · 80d
Cleared Jul 30, 1992
VORTECH'S PERSONAL DISPLAY SYSTEM
K922310 · LLZ
Vortech Data, Inc.
Radiology · 73d
Cleared Jul 30, 1992
BYRD TELESCOPING STAINLESS STEEL DILAT SHEATH SET
K922354 · GCC
Med Institute, Inc.
General & Plastic Surgery · 72d
Cleared Jul 30, 1992
REFLECTIONS - CERAMIC DENTAL BRACKET
K922499 · EJF
Cdb Corp.
Dental · 64d
Cleared Jul 30, 1992
TURKEL THORACENTESIS SYSTEM
K922614 · GAA
Symbiosis Corp.
General & Plastic Surgery · 58d
Cleared Jul 30, 1992
ZITHROMAX
K922792 · JNT
Difco Laboratories, Inc.
Microbiology · 51d
Cleared Jul 30, 1992
RAI-TROL FRUCTOSAMINE SERUM CONTROLS I AND II
K922904 · JJX
Reagents Applications, Inc.
Chemistry · 44d
Cleared Jul 30, 1992
RESTCUE CC
K922973 · IOQ
Support Systems Intl.
Physical Medicine · 38d
Cleared Jul 30, 1992
EURION LOTOS PP HEARING AID
K923226 · ESD
Eurion Hearing Instruments
Ear, Nose, Throat · 29d
Cleared Jul 30, 1992
AFFIRM PROCESSOR
K923268 · JQW
Microprobe Corp.
Chemistry · 24d
Cleared Jul 29, 1992
IL TEST(TM) HAPTOGLOBIN (HPT)
K915829 · DAD
Instrumentation Laboratory CO
Immunology · 212d
Cleared Jul 29, 1992
HAIR TRONICS MODEL HT8000
K915845 · KCX
Global Tronics Intl., Inc.
General & Plastic Surgery · 216d
Cleared Jul 29, 1992
IL TEST ALPHA-1-ANTITRYPSIN (AAT)
K920005 · DEM
Instrumentation Laboratory CO
Immunology · 209d
Cleared Jul 29, 1992
ITC BUNJI COIL (MODIFICATION)
K920324 · HCG
Interventional Therapeutics Corp.
Neurology · 187d
Cleared Jul 29, 1992
QQUADRATURE LUMBAR CONTOUR COIL
K922006 · LNH
Magnetic Research, Inc.
Radiology · 90d
Cleared Jul 28, 1992
BILIBLANKET LIGHT METER
K910571 · LBI
Ohmeda Medical
General Hospital · 533d
Cleared Jul 28, 1992
KTP/532 & KTP/YAG SURGICAL LASERS
K913244 · GEX
Charles L. Rose and Co., Inc.
General & Plastic Surgery · 372d
Cleared Jul 28, 1992
PYMAH COLD STERILOG GLUTARALDEHYDE MONITOR
K915170 · MED
Pymah Corp.
General Hospital · 256d
Cleared Jul 28, 1992
CYTOGUIDE STEREOTACTIC BIOPSY SYSTEM MODEL MF-CYTO
K915201 · IZH
Bennett X-Ray Corp.
Radiology · 253d
Cleared Jul 28, 1992
NOBLES-LAI IMAGING SYSTEM
K920026 · FET
Nobles-Lai Engineering, Inc.
Gastroenterology & Urology · 207d
Cleared Jul 28, 1992
POINTE 750 GLYCOMETER
K920449 · LCP
Pointe Scientific, Inc.,
Hematology · 177d
Cleared Jul 28, 1992
ORTHODONTIC ELASTICS BANDS
K920645 · EJF
Masel Industries, Inc.
Dental · 167d
Cleared Jul 28, 1992
LAPAROSCOPIC RETRACTOR SYSTEM
K921006 · GCS
Laparomed Corp.
Gastroenterology & Urology · 147d