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
105985–106008 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 22, 1994
JAMES LECKEY PRONE STANDER
K944307 · INW
James Leckey Design
Physical Medicine · 111d
Cleared Dec 22, 1994
JAMES LECKEY FREE STANDER
K944308 · INW
James Leckey Design
Physical Medicine · 111d
Cleared Dec 22, 1994
PM3300 INTERMITTENT VACUUM
K944479 · KDP
Precision Medical, Inc.
General Hospital · 100d
Cleared Dec 22, 1994
LECTROSURIGICAL, CUTTING AND COAGULATION AND ACCESSORIES
K944681 · GEI
Birtcher Medical Systems, Inc.
General & Plastic Surgery · 91d
Cleared Dec 22, 1994
ARCTIC PREMIER SERIES
K944700 · HOY
Sungold Eyewear, Inc.
Ophthalmic · 90d
Cleared Dec 22, 1994
OPTICA 100 SUPERPULSED LASER SYSTEM
K944749 · GEX
Xintec Corporation
General & Plastic Surgery · 87d
Cleared Dec 22, 1994
PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES
K945777 · JKA
Smiths Industries Medical Systems, Inc.
Chemistry · 27d
Cleared Dec 22, 1994
S-SCORT(R)DUET MODEL 2014 PORTABLE SUCTION PUMP
K945929 · BTA
Sscor
General & Plastic Surgery · 17d
Cleared Dec 21, 1994
APOGEE HIP STEM WITH POROCOAT
K934334 · LPH
Depuy, Inc.
Orthopedic · 470d
Cleared Dec 21, 1994
CONMED TROGARD
K934799 · HET
Conmedcorp
Obstetrics & Gynecology · 440d
Cleared Dec 21, 1994
DEROYAL CRITICAL CARE DISPOSABLE WASTE STATION
K935985 · DQO
Deroyal Industries, Inc.
Cardiovascular · 372d
Cleared Dec 21, 1994
PIONEER LABORATORIES BONE PLATE WITH CERCLAGE CABLES
K940729 · JDQ
Pioneer Surgical Technology
Orthopedic · 306d
Cleared Dec 21, 1994
KREATIV MODEL KV-1
K940776 · KOJ
Kreativ, Inc.
Dental · 302d
Cleared Dec 21, 1994
DEEP CANAL HEARING INSTRUMENT
K942702 · ESD
Rexton, Inc.
Ear, Nose, Throat · 196d
Cleared Dec 21, 1994
ELECTROSURGICAL CUTTING AND COAGULATING DEVICE AND ACCESSORIES
K943055 · GEI
Megadyne Medical Products, Inc.
General & Plastic Surgery · 177d
Cleared Dec 21, 1994
KARL STORZ HOPKINS I&II/OPER/AUTOCLAVABLE TELESCOPESQ
K943176 · FAJ
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 173d
Cleared Dec 21, 1994
DARWIN KNEE SYSTEM
K943462 · JWH
Johnson & Johnson Professionals, Inc.
Orthopedic · 156d
Cleared Dec 21, 1994
P.F.C. CEMENT PRESSURIZING SYSTEM
K943906 · KIH
Johnson & Johnson Professionals, Inc.
Orthopedic · 132d
Cleared Dec 21, 1994
ELECTROSURGICAL FLEXIBLE ELECTRODE IN-LINE SUCTION COAGULATOR
K944012 · GEI
Aspen Laboratories, Inc.
General & Plastic Surgery · 127d
Cleared Dec 21, 1994
IMAGE
K944161 · ESD
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 117d
Cleared Dec 21, 1994
HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR CATALOG NUMBERS:...
K944301 · BTM
Hudson Respiratory Care, Inc.
Anesthesiology · 106d
Cleared Dec 21, 1994
STYLET SHEATH WITH LOCKING CAP AND REUSABLE BATTERY OPERATED LIGHT SOURCE
K944729 · BSR
Coast Medical, Inc.
Anesthesiology · 86d
Cleared Dec 21, 1994
BIO-LOGIC EMAV EMISSION AVERAGING OTOACOUSTIC TEST
K944735 · EWO
Bio-Logic Systems Corp.
Ear, Nose, Throat · 86d
Cleared Dec 21, 1994
KARL STORZ UNIPOLAR BALL, NEEDLE, LOOP ELECTRODES
K944795 · FAS
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 84d