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
110305–110328 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 28, 1994
ARGISTAR 72 (HIGH GOLD PLATINUM SILVER ALLOY FOR BOTH LOW FUSING PORCELAIN...
K935973 · EJT
Argen Precious Metals, Inc.
Dental · 46d
Cleared Jan 28, 1994
BERMAN AIRWAY
K936134 · CAE
Smiths Industries Medical Systems, Inc.
Anesthesiology · 36d
Cleared Jan 27, 1994
HEMOCARD, HEMOGLOBIN C ASSAY
K923153 · MLL
Isolab, Inc.
Hematology · 577d
Cleared Jan 27, 1994
SPECTROLYSE HEPARIN KIT
K923499 · KFF
Biopool AB
Hematology · 561d
Cleared Jan 27, 1994
MDA PROTEIN ASSAY
K925617 · GGP
Organon Teknika Corp.
Hematology · 447d
Cleared Jan 27, 1994
ROCHE ABUSCREEN ONTRAK POS. REF. CONTROL-METHADONE
K930844 · LAS
Roche Diagnostic Systems, Inc.
Toxicology · 343d
Cleared Jan 27, 1994
DENTAL INSTRUMENTS CURETTE PERIODONTAL
K931329 · EMS
Minnesota Prophy Power, Inc.
Dental · 317d
Cleared Jan 27, 1994
UNIVERSAL BONE CEMENT KIT
K931540 · LZN
Biodynamic Technologies, Inc.
Orthopedic · 304d
Cleared Jan 27, 1994
IMMULITE PAP
K931701 · JFH
Diagnostic Products Corp.
Chemistry · 296d
Cleared Jan 27, 1994
PURECARE AT-903 T.E.N.S.
K931715 · GZJ
Fuching Enterprise Co., Ltd.
Neurology · 296d
Cleared Jan 27, 1994
M-FLEX 5000 C3PMD
K931736 · BXB
Medical Systems Corp.
Physical Medicine · 295d
Cleared Jan 27, 1994
SNAP OSCILLATING SAW
K931769 · GFA
Surgiquip, Inc.
General & Plastic Surgery · 293d
Cleared Jan 27, 1994
NAVARRE BIOMEDICAL UNIVERSAL DRAINAGE CATHETER SET
K932391 · GBX
Navarre Biomedical , Ltd.
General & Plastic Surgery · 254d
Cleared Jan 27, 1994
PMI TENS ELECTRODE
K932849 · GZJ
Pepin Mfg., Inc.
Neurology · 231d
Cleared Jan 27, 1994
BLOOD GAS MIXTURE
K932874 · BXK
Tri-Gas, Inc.
Anesthesiology · 227d
Cleared Jan 27, 1994
ISOTECHNOLOGIES BACK TRACKER AND BACK WORKS SOFTWA
K933063 · KQX
Isotechnologies, Inc.
Neurology · 219d
Cleared Jan 27, 1994
PROBES,SCISSORS,FORCEPS,GRASPERS,&NEEDLE HOLDERS
K933067 · GCJ
Medline Industries, Inc.
General & Plastic Surgery · 219d
Cleared Jan 27, 1994
IMC CABLE/WIRE COVER
K933382 · KKX
Inman Medical Corp.
General Hospital · 199d
Cleared Jan 27, 1994
SACRED CRANE TDP
K933584 · ILY
Telstar Innovations, Inc.
Physical Medicine · 185d
Cleared Jan 27, 1994
GEISTER SURGICAL INT'L BIPOLAR ENDOSCOPIC SURGICAL INSTRUMENTS
K933699 · GEI
Geister Medizin Technik GmbH
General & Plastic Surgery · 182d
Cleared Jan 27, 1994
TOA MEDICAL ELECTRONICS CA-5000
K933886 · JPA
Toa Medical Electronics USA, Inc.
Hematology · 170d
Cleared Jan 27, 1994
PASCO MIC PANELS/ GENT & STREP SYNERGY
K934380 · JWY
Pasco Laboratories, Inc.
Microbiology · 141d
Cleared Jan 27, 1994
NASOPHARYNGOSCOPE
K934422 · EOB
Marks & Murase
Ear, Nose, Throat · 136d
Cleared Jan 27, 1994
PNEUMATIC WIRE TENSIONER
K934431 · HSZ
Smith & Nephew Richards, Inc.
Orthopedic · 136d