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
113929–113952 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 22, 1993
BARD(R) BLOOD CARDIOPLEGIA HEAT EXCHANGER/TUBE SET
K930299 · DTN
C.R. Bard, Inc.
Cardiovascular · 152d
Cleared Jun 22, 1993
NARKOMED 2C ANESTHESIA SYSTEM
K930351 · BSZ
Draeger Medical, Inc.
Anesthesiology · 148d
Cleared Jun 22, 1993
SHERWOOD MEDICAL ARTERIAL BLOOD GAS KIT II
K930471 · CBT
Sherwood Medical Co.
Anesthesiology · 145d
Cleared Jun 22, 1993
QUANTUM 3080 SURGICAL TABLE
K930493 · FQO
American Sterilizer Co.
General & Plastic Surgery · 141d
Cleared Jun 22, 1993
E-25 KRYPTON ION LASER (SURGICA K5)
K930543 · GEX
Hgm, Inc.
General & Plastic Surgery · 140d
Cleared Jun 22, 1993
TECHNICON H* 3TM RTC SYSTEM (IN-VITRO DIAG.SYST.)
K930685 · GKL
Heraeus Kulzer, Inc.
Hematology · 132d
Cleared Jun 22, 1993
ENDOPATH ENDOSCOPIC SURGICAL INSTRUMENTS
K930933 · GCJ
Ethicon, Inc.
General & Plastic Surgery · 119d
Cleared Jun 22, 1993
ENDOPATH DISPOSABLE FLEXIBLE SURGICAL CANNULA
K931111 · GCJ
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 110d
Cleared Jun 22, 1993
RUSCH AGT PVC PREF NASAL TRACH TUB/UNCUF W/MUR EYE
K931165 · BTR
Rusch, Inc.
Anesthesiology · 106d
Cleared Jun 22, 1993
RUSCH AGT PVC PREF ORAL TRACH TUBE, UNCUF W/MUR EY
K931166 · BTR
Rusch, Inc.
Anesthesiology · 106d
Cleared Jun 22, 1993
ENDOPATH* DISPOSABLE INTRODUCER
K931237 · GCJ
Ethicon, Inc.
General & Plastic Surgery · 103d
Cleared Jun 22, 1993
ENDOPATH DISPOSABLE KNOT PUSHER
K931238 · GCJ
Ethicon, Inc.
General & Plastic Surgery · 103d
Cleared Jun 22, 1993
DW207 #28G, DW207 #35F, DW207 #39LC
K931365 · EJT
Ivoclar North America, Inc.
Dental · 97d
Cleared Jun 22, 1993
CADWELL 6200 A
K931428 · GWF
Cadwell Laboratories, Inc.
Neurology · 88d
Cleared Jun 22, 1993
NCA-200
K931608 · KHH
Ics Medical Corp.
Ear, Nose, Throat · 82d
Cleared Jun 22, 1993
QUICKVUE(TM) ONE-STEP HCG CONTROLS (POSIT/NEGATI)
K931761 · JJX
Quidel Corp.
Chemistry · 75d
Cleared Jun 22, 1993
AUDIOTECH MODEL DP
K931975 · ESD
Muskogee Regional Hearing Aid Lab
Ear, Nose, Throat · 61d
Cleared Jun 22, 1993
AMBU DISPOSABLE FACE MASK
K932014 · BSJ
Ambu, Inc.
Anesthesiology · 60d
Cleared Jun 22, 1993
ENDOPATH II DISPOSABLE SURGICAL TROCAR & SLEEVE
K932282 · GCJ
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 41d
Cleared Jun 21, 1993
SERIOUS SKINGLASSES
K922120 · HQY
Serious Skinglasses
Ophthalmic · 412d
Cleared Jun 21, 1993
MMELALENS SUNGLASSES
K923746 · HQY
Dwh, Inc.
Ophthalmic · 328d
Cleared Jun 21, 1993
SMITH RIVER MICROBIOLOGICAL CULTURE MEDIA
K923892 · JSO
Smith River Biologicals
Microbiology · 321d
Cleared Jun 21, 1993
MODEL #12000 BINOCULAR INDERECT OPHTHALMOSCOPE
K930023 · HLI
Welch Allyn, Inc.
Ophthalmic · 167d
Cleared Jun 21, 1993
THYRUS
K930283 · IYX
Adac Laboratories
Radiology · 151d