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
102289–102312 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 20, 1995
N LATEX IGA
K952309 · CZP
Behring Diagnostics, Inc.
Immunology · 34d
Cleared Jun 20, 1995
CONTRAST & RAPID HCG URINE/SERUM TST
K952319 · JHI
Medix Biotech, Inc.
Chemistry · 33d
Cleared Jun 20, 1995
3.3MM ACCESSORIES
K952448 · DZE
Nobelpharma USA, Inc.
Dental · 26d
Cleared Jun 19, 1995
MULTI-DOP S
K926363 · IYO
Dantec Medical, Inc.
Radiology · 910d
Cleared Jun 19, 1995
LAPAROSCOPIC SURGERY INSTRUMENTS
K932033 · GCJ
Medline
General & Plastic Surgery · 783d
Cleared Jun 19, 1995
SIGNA ADVANTAGE MAGNETIC RESONANCE SYSTEM-HISPEED PERFORMANCE OPTIONS
K941666 · LNH
General Electric Co.
Radiology · 440d
Cleared Jun 19, 1995
ADVANCED NMR SYST INSTASCAN/MODIF: T1 & TE STEPPING
K944070 · LNH
Advanced Nmr Systems, Inc.
Radiology · 304d
Cleared Jun 19, 1995
T-300 COOLER
K945468 · ILO
Temptek, Inc.
Physical Medicine · 223d
Cleared Jun 19, 1995
COATED TUNGSTEN EYESHIELD
K945515 · IWS
Medtec, Inc.
Radiology · 222d
Cleared Jun 19, 1995
WITT BIOMEDICAL IMAGE III
K945582 · LLZ
Witt Biomedical Corporation
Radiology · 217d
Cleared Jun 19, 1995
HEMO-BARRIER TOURNIQUET
K950258 · EFQ
Hemo-Barrier Technologies, Inc.
General & Plastic Surgery · 147d
Cleared Jun 19, 1995
KARL STORZ INFANT, BALLOON VAGINOSCOPE, VAGINOSCOPE SHEATH, FIBER OPTIC LIGHT...
K950639 · MOK
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 126d
Cleared Jun 19, 1995
CIBA CORNING ACS VANCOMYCIN IMMUNOASSAY
K951059 · LEH
Ciba Corning Diagnostics Corp.
Toxicology · 104d
Cleared Jun 19, 1995
PULSE KLYSTRON AMPLIFIFER (L-5822-90)
K951143 · IYE
Litton Systems, Inc.
Radiology · 98d
Cleared Jun 19, 1995
VMI 1000 SURGICAL PACEOMETER
K951145 · ITX
Vision Medical Instruments, Inc.
Radiology · 98d
Cleared Jun 19, 1995
PARAMAX ALANINE AMINOTRANSFERASE (GPT) REAGENT
K951332 · CKA
Dade Intl., Inc.
Chemistry · 102d
Cleared Jun 19, 1995
VARIOUS UHMWP HIP & KNEE JOINT PROSTHESIS MODIFIED
K951356 · LPH
Biologically Oriented Prostheses
Orthopedic · 87d
Cleared Jun 19, 1995
ZOMED MODEL 10 CAUTERY BIOPSY DEVICE
K951659 · GEI
Zomed Intl.
General & Plastic Surgery · 70d
Cleared Jun 19, 1995
ELI URINE CONTROLS
K951817 · DIF
Elsohly Labs, Inc.
Chemistry · 60d
Cleared Jun 19, 1995
WIDEX MODEL LOGO 32 (L32)
K952229 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 38d
Cleared Jun 19, 1995
LEGEND
K952441 · INQ
Health Care Mfg., Inc.
Physical Medicine · 25d
Cleared Jun 16, 1995
AIR CLEANERS WITH HEPA FILTRATION
K930521 · FRF
The Rival Co.
General Hospital · 864d
Cleared Jun 16, 1995
AROMATIC CONDOM, ESSENTIALS, MI VIDA & JIFFI
K932985 · HIS
Sime Health, Ltd.
Obstetrics & Gynecology · 728d
Cleared Jun 16, 1995
MMS-2400
K941843 · BZC
Parvo Medics, Inc.
Anesthesiology · 428d