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
109489–109512 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 07, 1994
PICC INSERTION TRAY
K931668 · FOZ
Clinipad Corp.
General Hospital · 335d
Cleared Mar 07, 1994
SURETIP SYRINGE TIP COVER
K931772 · ECB
Western M/D, Inc.
Dental · 332d
Cleared Mar 07, 1994
CARAPACE PELVIC EXAM TRAYS
K931822 · MLT
Carapace, Inc.
Obstetrics & Gynecology · 333d
Cleared Mar 07, 1994
GAMMA LOCKING NAIL-CROSS LOCKING SCREWS
K932174 · KTT
Howmedica Corp.
Orthopedic · 306d
Cleared Mar 07, 1994
RELIANT
K932397 · LKY
Allan Walling Medical Equipment Co.
Gastroenterology & Urology · 293d
Cleared Mar 07, 1994
S*E*M*M-SET & C*U*R*T-SET
K932617 · GCJ
Market-Tiers, Inc.
General & Plastic Surgery · 279d
Cleared Mar 07, 1994
ULTAR-SHIELD
K932702 · LYY
Medical Resources International, Inc.
General Hospital · 277d
Cleared Mar 07, 1994
FLOWSCREEN
K932744 · BTY
Erich Jaeger, Inc.
Anesthesiology · 272d
Cleared Mar 07, 1994
SEAC MOBILE UNIT BY ASI MEDICAL
K932873 · EIA
Asi Medical, Inc.
Dental · 266d
Cleared Mar 07, 1994
PLAYTEX ULTIMATES TAMPONS
K932907 · HIL
Playtex Family Products, Inc.
Obstetrics & Gynecology · 264d
Cleared Mar 07, 1994
PLAYTEX ULTIMATES TAMPONS
K932909 · HIL
Playtex Family Products, Inc.
Obstetrics & Gynecology · 264d
Cleared Mar 07, 1994
PEGASUS BIWAVE SYSTEM
K933004 · FNM
Pegasus Airwave, Inc.
General Hospital · 259d
Cleared Mar 07, 1994
DAWN DISPOSABLE BIOPSY FORCEPS
K933135 · FCL
Dawn Medical
Gastroenterology & Urology · 252d
Cleared Mar 07, 1994
IMPLA-MED UCLA TYPE ABUTMENTS,SCREWDRIVER,REAMER,L
K933193 · DZE
The Stern Metals Co., Inc.
Dental · 250d
Cleared Mar 07, 1994
ACU-DISPO-CE(TM)
K933265 · MDM
Acuderm, Inc.
General & Plastic Surgery · 244d
Cleared Mar 07, 1994
OSTEONICS 22MM, +10 NECK BEARING HEADS
K933359 · LWJ
Osteonics Corp.
Orthopedic · 241d
Cleared Mar 07, 1994
CONICAL ABUTMENT
K933462 · DZE
Implant Innovations, Inc.
Dental · 234d
Cleared Mar 07, 1994
SPECULUM
K933521 · HIB
Bioteque America, Inc.
Obstetrics & Gynecology · 230d
Cleared Mar 07, 1994
RESOLUTION(TM) HIP STEM
K933570 · LJW
Wrightmedicaltechnologyinc
Ear, Nose, Throat · 227d
Cleared Mar 07, 1994
EAGLE MEDICAL ANTI-FOG KIT
K933618 · OCT
Eagle Medical Intl.
Gastroenterology & Urology · 231d
Cleared Mar 07, 1994
MASTER SCREEN PNUEMO
K933839 · BTY
Erich Jaeger, Inc.
Anesthesiology · 214d
Cleared Mar 07, 1994
STORZ FIBEROPTIC PICK MANIPULATOR
K933907 · HQE
Storz Instrument Co.
Ophthalmic · 208d
Cleared Mar 07, 1994
PLAYTEX ULTIMATES TAMPONS
K934083 · HIL
Playtex Family Products, Inc.
Obstetrics & Gynecology · 199d
Cleared Mar 07, 1994
DEROYAL SURGICAL DISPOSABLE INSUFFLATION TUBING
K934131 · HIF
Deroyal Industries, Inc.
Obstetrics & Gynecology · 194d