FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
136345–136368 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 18, 1988
STREPTOSEL
K881578 · JSJ
Acumedia Manufacturers, Inc.
Microbiology · 7d
Cleared Apr 18, 1988
AMIES TRANSPORT MEDIUM W/O CHARCOAL
K881579 · JSN
Acumedia Manufacturers, Inc.
Microbiology · 7d
Cleared Apr 15, 1988
GLANDOSANE (SALIVART) SYNTHETIC SALIVA
K874106 · LFD
Fresenius USA, Inc.
Dental · 189d
Cleared Apr 15, 1988
TRANS/R NEEDLE GUIDE
K875128 · IYO
CIVCO Medical Instruments Co., Inc.
Radiology · 122d
Cleared Apr 15, 1988
TRANS/P NEEDLE GUIDE
K875236 · IYO
CIVCO Medical Instruments Co., Inc.
Radiology · 115d
Cleared Apr 15, 1988
TRANS/V NEEDLE GUIDE
K875240 · IYO
CIVCO Medical Instruments Co., Inc.
Radiology · 115d
Cleared Apr 15, 1988
EMPI MODEL 989, TENS
K881114 · GZJ
Empi
Neurology · 31d
Cleared Apr 15, 1988
ACE PNEUMATIC OSCILLATING SAW
K881250 · HSZ
Buckman Co., Inc.
Orthopedic · 23d
Cleared Apr 14, 1988
VITALERT 1000 MONITORING SYSTEM
K873380 · CCK
Draeger Medical, Inc.
Anesthesiology · 234d
Cleared Apr 14, 1988
BODAI NEO2-SAFE(TM)
K873696 · BZA
B&B Medical Technologies, Inc.
Anesthesiology · 213d
Cleared Apr 14, 1988
DANTEC 13L40 ST. MARKS'S PUDENDAL ELECTRODE
K874758 · FAP
Dantec Electronics, Inc.
Gastroenterology & Urology · 148d
Cleared Apr 14, 1988
13L81 DISPOSABLE SPHINCTER ELECTRODE, 13L33 CABLE
K874759 · FAP
Dantec Electronics, Inc.
Gastroenterology & Urology · 148d
Cleared Apr 14, 1988
MEDSURG PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TRAY
K874936 · KNT
Medsurg Industries, Inc.
Gastroenterology & Urology · 132d
Cleared Apr 14, 1988
TOOTH PRESERVING SYSTEM
K875221 · KJF
Biological Rescue Products, Inc.
Pathology · 114d
Cleared Apr 14, 1988
CIVCO SEED IMPLANT NEEDLE GUIDE
K875241 · IYO
CIVCO Medical Instruments Co., Inc.
Radiology · 114d
Cleared Apr 14, 1988
CHURCHILL 0.22 MICRON LIQUID FILTER SETS
K880025 · FPB
Churchill Corp.
General Hospital · 100d
Cleared Apr 14, 1988
CHURCHILL 0.22 MICRON LIQUID COMPACT FILTER SETS
K880026 · FPB
Churchill Corp.
General Hospital · 100d
Cleared Apr 14, 1988
ENTERAL BAG/SET
K880051 · KNT
Churchill Corp.
Gastroenterology & Urology · 99d
Cleared Apr 14, 1988
CPU 1100 VENTILATOR
K880054 · CBK
Ohmeda Medical
Anesthesiology · 98d
Cleared Apr 14, 1988
PORTABLE THERAPEUTIC LIQUID OXYGEN UNIT
K880183 · BYJ
Essex Cryogenics of Missouri, Inc.
Anesthesiology · 90d
Cleared Apr 14, 1988
MODEL 4060 N ND:YAG LASER FOR UROLOGICAL USE
K880193 · LNK
Sharplan Lasers, Inc.
Gastroenterology & Urology · 86d
Cleared Apr 14, 1988
REPLACEMENT SILICONE GASTROSTOMY TUBE KIT #87600
K880201 · KNT
Superior Healthcare Group, Inc.
Gastroenterology & Urology · 90d
Cleared Apr 14, 1988
HERMAN CANNULA SET
K880203 · HRX
Orthopedic Systems, Inc.
Orthopedic · 90d
Cleared Apr 14, 1988
MODEL 4060 N ND:YAG LASER FOR GASTROENTEROLOGY USE
K880256 · LNK
Sharplan Lasers, Inc.
Gastroenterology & Urology · 85d