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
100969–100992 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 14, 1995
BLOCK(TM) ARTHROSCOPIC TOOL KIT
K946174 · HRX
Johnson
Orthopedic · 269d
Cleared Sep 14, 1995
NIDEK MODEL GYC-1500 AND GYC-2000
K951079 · HQF
Nidek, Inc.
Ophthalmic · 189d
Cleared Sep 14, 1995
ENDOSCOPES, FIBER OPTIC LAPAROSCOPES, (STERILIZABLE)
K951482 · GCJ
Micro-Medical Devices, Inc.
General & Plastic Surgery · 168d
Cleared Sep 14, 1995
POWERSCULPTOR PROBES
K952755 · GEX
Cardiogenes
General & Plastic Surgery · 91d
Cleared Sep 14, 1995
CYLINDRICAL SPONGE
K953057 · GDY
Medical Perspectives Corp.
General & Plastic Surgery · 76d
Cleared Sep 14, 1995
ROUND STICK SPONGES, FLAT STICK SPONGES
K953058 · GDY
Medical Perspectives Corp.
General & Plastic Surgery · 76d
Cleared Sep 14, 1995
KITTNER DISSECTOR
K953059 · GDY
Medical Perspectives Corp.
General & Plastic Surgery · 76d
Cleared Sep 14, 1995
ROSEBUD DISSECTOR
K953060 · GDY
Medical Perspectives Corp.
General & Plastic Surgery · 76d
Cleared Sep 14, 1995
CHERRY DISSECTOR
K953062 · GDY
Medical Perspectives Corp.
General & Plastic Surgery · 76d
Cleared Sep 14, 1995
CHERRY PIT DISSECTOR
K953087 · GDY
Medical Perspectives Corp.
General & Plastic Surgery · 73d
Cleared Sep 14, 1995
TRIANGULAR SPONGES
K953088 · GDY
Medical Perspectives Corp.
General & Plastic Surgery · 73d
Cleared Sep 14, 1995
ROTATING, FIXED FOOTED, FIXED SHIELD ATTACHMENTS, DISSECTING TOOLS
K953432 · GET
Midas Rex Pneumatic Tools, Inc.
General & Plastic Surgery · 55d
Cleared Sep 14, 1995
TAPERTIP MULTISUE HOLMIUM ARTHROSCOPIC HANDPIECE, VARIOUS ENDFIRING MODELS,...
K953494 · GEX
Trimedyne, Inc.
General & Plastic Surgery · 51d
Cleared Sep 14, 1995
STORZ MVS-3201 VITRECTOMY PROBE PACK
K953575 · HQE
Storz Instrument Co.
Ophthalmic · 45d
Cleared Sep 14, 1995
STORZ DP4505 VITREOUS MEMBRANE DISSECTOR
K953576 · HQE
Storz Instrument Co.
Ophthalmic · 45d
Cleared Sep 14, 1995
FLUFF GAUZE BANDAGE, STERILE & NON-STERILE
K953810 · EFQ
K. W. Griffen Co.
General & Plastic Surgery · 37d
Cleared Sep 14, 1995
TAKE-APART SCISSORS
K954122 · GEI
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 13d
Cleared Sep 13, 1995
DYNATRON 650
K950348 · LIH
Dynatronics Corp.
Neurology · 229d
Cleared Sep 13, 1995
DYNATRON 950
K950349 · LIH
Dynatronics Corp.
Neurology · 229d
Cleared Sep 13, 1995
DISPOSABLE ECG MONITORING ELECTRODE #4600 60MM, #4610 45MM
K950479 · DRX
Nikomed U.S.A., Inc.
Cardiovascular · 222d
Cleared Sep 13, 1995
W2 WRIST CPM UNIT
K950682 · BXB
Toronto Medical Corp.
Physical Medicine · 211d
Cleared Sep 13, 1995
KODAK EKTASCAN TRIAD LASER PRINTER SYSTEM, PHOTON LASER PRINTER
K951807 · LMC
Kodak Health Imaging Systems, Inc.
Radiology · 147d
Cleared Sep 13, 1995
KODAK XLS 8600 (PS)
K951948 · LMC
Kodak Health Imaging Systems, Inc.
Radiology · 140d
Cleared Sep 13, 1995
PLEXUS/3000 (P/3000), PLEXUS/3500 (P/3500)
K952610 · FNM
Plexus Medical
General Hospital · 98d