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
121969–121992 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 28, 1991
L328 TRANSDUCER
K905456 · MAA
Acuson Corp.
Radiology · 175d
Cleared May 28, 1991
3M 6830 ELECTRODE
K905539 · GXY
3M Healthcare
Neurology · 168d
Cleared May 28, 1991
AMBU SIR 2 (SILICONE RESUSCITATOR), ADULT
K910040 · BTM
Ambu, Inc.
Anesthesiology · 144d
Cleared May 28, 1991
FLOWPLUS AC330 PUMP GARMENTS
K910188 · JOW
Huntleigh Technology, Inc.
Cardiovascular · 132d
Cleared May 28, 1991
PHILIPS INTEGRIS V3000 AND V4000
K910370 · IZI
Philips Medical Systems, Inc.
Radiology · 119d
Cleared May 28, 1991
URAM OPHTHALMIC LASER ENDOSCOPE
K910532 · HQF
Martin S. Knopf Assoc., Inc.
Ophthalmic · 109d
Cleared May 28, 1991
AUTOCATH(TM) SET
K910876 · GBM
Cook Urological, Inc.
Gastroenterology & Urology · 88d
Cleared May 28, 1991
MOSS NASAL TUBE MARK IV
K910912 · KNT
Moss Medical Products
Gastroenterology & Urology · 84d
Cleared May 28, 1991
HSV-2 IGG ELISA TEST
K910952 · LGC
Gull Laboratories, Inc.
Microbiology · 82d
Cleared May 28, 1991
HSV-2 IGM ELISA TEST
K910953 · LGC
Gull Laboratories, Inc.
Microbiology · 82d
Cleared May 28, 1991
HSV-1 IGG ELISA TEST
K910954 · LGC
Gull Laboratories, Inc.
Microbiology · 83d
Cleared May 28, 1991
HSV-1 IGM ELISA TEST
K910955 · LGC
Gull Laboratories, Inc.
Microbiology · 83d
Cleared May 28, 1991
MODEL BAXTER ULTRAFILTRATE METER AND DRAIN BAG
K911106 · KOC
Baxter Healthcare Corp
Gastroenterology & Urology · 77d
Cleared May 28, 1991
BARD(R) SURECATCH PEDIATRIC URINE COLLECT DEVICE
K911329 · FOC
C.R. Bard, Inc.
Gastroenterology & Urology · 63d
Cleared May 28, 1991
SR1 ESTRADIOL ENZYME IMMUNOASSAY
K911396 · CHP
Serono-Baker Diagnostics, Inc.
Chemistry · 60d
Cleared May 28, 1991
ABBOTT LIFECARE 5000 PUMP
K911401 · FRN
Abbott Laboratories
General Hospital · 60d
Cleared May 28, 1991
STAK-CHEX
K911582 · JCN
Streck Laboratories, Inc.
Hematology · 50d
Cleared May 28, 1991
MEDI GUARD PILLOWCASE
K911948 · KME
Sancella, Inc.
General Hospital · 27d
Cleared May 28, 1991
MEDI GUARD UNDERPAD
K911952 · KME
Sancella, Inc.
General Hospital · 27d
Cleared May 28, 1991
MEDI GUARD SHEETS/UNDERLAYS
K911953 · KME
Sancella, Inc.
General Hospital · 27d
Cleared May 28, 1991
WIDEX MODEL QX IN-THE-EAR HEARING AID
K912169 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 12d
Cleared May 24, 1991
ND:YAG LASER SYSTEMS (VARIOUS MODELS)
K910805 · HQF
Heraeus Lasersonics, Inc.
Ophthalmic · 87d
Cleared May 24, 1991
SRI TSH IMMUNENZYMETRIC ASSAY
K910837 · JLW
Serono-Baker Diagnostics, Inc.
Chemistry · 86d
Cleared May 23, 1991
CARDIOCAP II TM CH-RESP MONITORS
K904355 · DPS
Instrumentarium Corp.
Cardiovascular · 241d