Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Applied Medical Resources · Predicate Candidate Screening
58 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
97 daysmedian FDA review time
329 days90th percentile
58clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K200021 | Applied Medical Anoscope | Applied Medical Resources | 2021-01-06 | 366 | 0 |
| K162676 | Voyant Open Fusion Device | Applied Medical Resources | 2016-12-01 | 66 | 0 |
| K153017 | Voyant Fine Fusion | Applied Medical Resources | 2016-07-06 | 265 | 0 |
| K153288 | Voyant Open Fusion Device | Applied Medical Resources | 2016-06-01 | 201 | 0 |
| K151480 | Epix Electrosurgical Probe with Smoke Evacuation | Applied Medical Resources | 2016-02-19 | 262 | 0 |
| K143308 | GelPOINT Transvaginal Access Platform | Applied Medical Resources | 2015-10-13 | 329 | 0 |
| K143536 | Voyant Fine Fusion Device | Applied Medical Resources | 2015-04-16 | 122 | 0 |
| K143517 | Voyant Open Sealer-Divider Device | Applied Medical Resources | 2015-03-27 | 105 | 1 |
| K142427 | TISSUE CONTAINMENT SYSTEM; 10, 14, 17, 25 | Applied Medical Resources | 2014-12-23 | 116 | 0 |
| K141288 | VOYANT ELECTROSURGICAL GENERATOR, VOYANT 5MM LAPAROSCOPIC SE | Applied Medical Resources | 2014-08-22 | 98 | 0 |
| K100959 | SPECIMEN RETRIEVAL SYSTEM | Applied Medical Resources | 2010-04-22 | 15 | 0 |
| K062907 | ALEXIS WOUND RETRACTOR | Applied Medical Resources | 2007-01-09 | 104 | 0 |
| K032889 | OPTICAL SEPARATOR | Applied Medical Resources | 2003-10-02 | 15 | 0 |
| K000545 | SENTRY EXPANDING INTRODUCER SHEATH (EIS) | Applied Medical Resources | 2000-05-02 | 74 | 0 |
| K993650 | URETERAL ACCESS SHEATH SET - NEW MODELS | Applied Medical Resources | 1999-12-28 | 60 | 0 |
| K993135 | IMPLANTABLE CLIP FOR GENERAL SURGERY | Applied Medical Resources | 1999-12-01 | 72 | 0 |
| K992852 | SUTURE CLINCH | Applied Medical Resources | 1999-11-22 | 90 | 0 |
| K991219 | C-FLEX URETERAL STENTS | Applied Medical Resources | 1999-06-21 | 70 | 6 |
| K983154 | CYSTIC DUCT BALLOON DILATING CATHETER | Applied Medical Resources | 1999-05-05 | 238 | 0 |
| K990775 | URETERAL ACCESS SHEATH SET | Applied Medical Resources | 1999-04-21 | 43 | 0 |
| K983744 | MCAS (MODULAR CLIP APPLIER SYSTEM) | Applied Medical Resources | 1999-01-21 | 90 | 0 |
| K973465 | LATIS GRAFT CLEANING CATHETER | Applied Medical Resources | 1998-02-19 | 160 | 1 |
| K973891 | LAPAROSCOPIC GASTROSTOMY KIT | Applied Medical Resources | 1998-01-12 | 90 | 0 |
| K962777 | AMR MINI-LAPAROSCOPE | Applied Medical Resources | 1997-08-06 | 385 | 0 |
| K971498 | APPLIED MEDICAL LAPAROSCOPIC GUIDEWIRE | Applied Medical Resources | 1997-05-05 | 10 | 0 |
| K963886 | EVS | Applied Medical Resources | 1997-04-24 | 210 | 0 |
| K970762 | DUAL LUMEN EMBOLECTOMY CATHETER | Applied Medical Resources | 1997-03-28 | 25 | 2 |
| K964470 | APPLIED MEDICAL CLIP APPLIER | Applied Medical Resources | 1997-01-22 | 76 | 0 |
| K962668 | AMR-ACV CLAMPS | Applied Medical Resources | 1996-11-04 | 118 | 0 |
| K963359 | INSUFFLATION NEEDLE | Applied Medical Resources | 1996-09-24 | 29 | 0 |
| K962395 | SPECIMEN RETRIEVAL BAG | Applied Medical Resources | 1996-07-05 | 15 | 0 |
| K951721 | APPLIED MEDICAL 1.5MM REUSABLE ANGIOSCOPE | Applied Medical Resources | 1995-07-11 | 88 | 0 |
| K950702 | LAPAROSCOPIC CLAMP | Applied Medical Resources | 1995-05-25 | 99 | 0 |
| K950586 | AVD INTIMAX THROMBECTOMY CATHETER | Applied Medical Resources | 1995-05-15 | 95 | 0 |
| K950492 | ATRAUMAX SURGICAL CLAMP | Applied Medical Resources | 1995-05-08 | 91 | 0 |
| K945741 | TROCAR AND CANNULA ACCESSORY | Applied Medical Resources | 1995-02-28 | 97 | 4 |
| K945591 | APPLIED MEDICAL OPTICAL VALVULOTOME | Applied Medical Resources | 1995-02-10 | 88 | 0 |
| K950267 | URETHRAL SUTURE GUIDE | Applied Medical Resources | 1995-01-31 | 8 | 0 |
| K944790 | FLEXIBLE LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER | Applied Medical Resources | 1994-11-29 | 62 | 0 |
| K944135 | UROLOGICAL GUIDWIRE | Applied Medical Resources | 1994-09-21 | 28 | 0 |
| K943489 | DISPOSABLE SURGICAL TROCAR | Applied Medical Resources | 1994-08-09 | 21 | 0 |
| K941011 | ACU-SIZER(TM) | Applied Medical Resources | 1994-06-13 | 102 | 0 |
| K941010 | ACUCISE GUIDEWIRE EXCHANGE SHEATH | Applied Medical Resources | 1994-04-18 | 46 | 0 |
| K941012 | LOW PRESSURE TAMPONADE BALLOON CATHETER | Applied Medical Resources | 1994-04-18 | 46 | 0 |
| K933498 | EXTERNAL VEIN STRIPPER | Applied Medical Resources | 1994-03-23 | 247 | 0 |
| K924481 | INSUFFLATION TUBING | Applied Medical Resources | 1994-03-22 | 565 | 0 |
| K923568 | TROCAR STABILITY THREAD | Applied Medical Resources | 1993-12-23 | 524 | 0 |
| K923636 | TROCAR W/ BLUNT TIP OBTURATOR | Applied Medical Resources | 1993-11-05 | 472 | 1 |
| K930758 | DIAGNOSTIC INTRAVASCULAR CATHETER | Applied Medical Resources | 1993-09-24 | 224 | 0 |
| K932995 | SURGICAL TROCAR AND CANNULA | Applied Medical Resources | 1993-09-23 | 97 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda